JP2018099630A - Methods and apparatus for blood flow restoration - Google Patents

Methods and apparatus for blood flow restoration Download PDF

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JP2018099630A
JP2018099630A JP2018068017A JP2018068017A JP2018099630A JP 2018099630 A JP2018099630 A JP 2018099630A JP 2018068017 A JP2018068017 A JP 2018068017A JP 2018068017 A JP2018068017 A JP 2018068017A JP 2018099630 A JP2018099630 A JP 2018099630A
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thrombus
distal segment
distal
blood flow
microcatheter
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ハワード スリー アール
Earl Howard Slee
ハワード スリー アール
ワイルダー サード トーマス
Thomas Wilder Iii
ワイルダー サード トーマス
マッカーシー トーマス
Thomas Mccarthy
マッカーシー トーマス
フランコ デイヴィッド
David Franco
フランコ デイヴィッド
フィリップ アシュビー マーク
Mark Philip Ashby
フィリップ アシュビー マーク
シュリヴァスタヴァ サンジャイ
Sanjay Shrivastava
シュリヴァスタヴァ サンジャイ
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Covidien LP
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    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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    • AHUMAN NECESSITIES
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61B2017/22038Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • AHUMAN NECESSITIES
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    • A61B2017/22051Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
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    • A61B2017/22094Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes

Abstract

PROBLEM TO BE SOLVED: To provide methods and apparatus for blood flow restoration.SOLUTION: The invention provides methods for restoring a blood flow in occluded blood vessels using an apparatus having a self-expandable distal segment that is pre-formed to assume a superimposed structure in an unconstrained condition but can be made to take on a volume-reduced form making it possible to introduce it with a microcatheter and a push wire arranged at the proximal end, with the distal segment in its superimposed structure assuming the form of a longitudinally open tube and having a mesh structure of interconnected strings or filaments or struts. In a preferred embodiment, the distal segment has a tapering structure at its proximal end where the strings or filaments or struts converge at a connection point.SELECTED DRAWING: Figure 5

Description

(関連出願の説明) (Description of related applications)

本出願は、米国特許法第119条e項の下に、2008年2月22日に出願された米国仮特許出願第61/030838号の恩典を主張する。この特許出願の明細書はその全体
が本明細書に参照として含まれる。
This application claims the benefit of US Provisional Patent Application No. 61/030838, filed February 22, 2008, under Section 119e of the US Patent Act. The specification of this patent application is hereby incorporated by reference in its entirety.

本発明は閉塞された血管、特に閉塞された大脳動脈において、血流を迅速にまたは即時に回復させるための方法及び装置に関する。さらに、本発明はそのような装置の血栓除去及び/または血栓溶解への適用に関する。   The present invention relates to a method and apparatus for rapid or immediate recovery of blood flow in occluded blood vessels, particularly occluded cerebral arteries. Furthermore, the invention relates to the application of such a device to thrombus removal and / or thrombolysis.

血栓によって閉塞された大脳動脈を処置するための現行技術では、動脈内の血流の回復に数時間かかり得る。さらに、大脳血栓を処置するための既知の装置及び方法は血栓の溶解に有効ではないかまたはある程度しか有効ではなく、さらに遠位塞栓形成または無関係の動脈の塞栓形成をおこすことがあり得る。神経学的永久欠損のリスク及び程度は、症状発生から血流回復までの時間が長くなるとともに急速に高くなる。   Current techniques for treating cerebral arteries occluded by a thrombus can take hours to restore blood flow in the artery. In addition, known devices and methods for treating cerebral thrombi are not or only partially effective at thrombolysis, and may cause distal embolization or irrelevant arterial embolization. The risk and extent of permanent neurological deficits increases rapidly with increasing time from symptom onset to blood flow recovery.

本発明は血栓で閉塞された血管部位における局所血流を回復させる方法に向けられる。本発明の方法は血栓で閉塞された大脳動脈の血管再生の速度及び有効性を向上させると考えられる。   The present invention is directed to a method for restoring local blood flow in a blood vessel site occluded with a thrombus. The method of the present invention is believed to improve the speed and effectiveness of revascularization of cerebral arteries occluded with thrombus.

一実施形態において、閉塞された動脈内の血流を、装置を展開すると即時に、生じさせる(または回復させる)ための方法及び装置が提供される。一態様において、自動展開式装置が血栓に径方向に隣接する部位に送り込まれ、装置が展開して血流を回復させる。   In one embodiment, a method and apparatus is provided for generating (or restoring) blood flow in an occluded artery immediately upon deployment of the apparatus. In one aspect, the self-deploying device is delivered to a site that is radially adjacent to the thrombus and the device is deployed to restore blood flow.

別の実施形態において、本発明は血栓によって閉塞された血管内の血流を、血管からの血栓の引剥し及び血栓の除去における効率を高めて、回復させる方法及び装置に向けられる。この実施形態においては、自動展開式装置が血栓に径方向に隣接する部位に送り込まれ、次いで展開する。次いで展開した装置が血流を回復させ、回復した血流が血管壁からの血栓の引剥しを補助する。一実施形態において、装置が血栓に絡み付き、次いで血栓を閉塞部位から除去することができる。   In another embodiment, the present invention is directed to a method and apparatus for restoring blood flow in a blood vessel occluded by a thrombus with increased efficiency in detaching and removing the thrombus from the blood vessel. In this embodiment, the self-expanding device is delivered to a site radially adjacent to the thrombus and then deployed. The deployed device then restores blood flow and the restored blood flow assists in the removal of the thrombus from the vessel wall. In one embodiment, the device can entangle the thrombus and then remove the thrombus from the occlusion site.

また別の実施形態において、本発明は閉塞された動脈内の血流を、血管から血栓の一部分または全てを溶解する効率を高め、必要に応じて装置を引き戻して、回復させる方法及び装置に向けられる。この実施形態においては、自動展開式装置が血栓に径方向に隣接する部位に送り込まれ、次いで展開する。展開してしまうと、装置は次いで閉塞された部位に血流を回復させ、この高められた血流が血栓を溶解させるかあるいはある程度または実質的に溶解させることができ、次いで装置−血栓複合体が以前は閉塞されていた部位から除去される。   In yet another embodiment, the present invention is directed to a method and apparatus for restoring blood flow in an occluded artery by increasing the efficiency of lysing some or all of the thrombus from the blood vessel and withdrawing the device as needed. It is done. In this embodiment, the self-expanding device is delivered to a site radially adjacent to the thrombus and then deployed. Once deployed, the device can then restore blood flow to the occluded site, and this enhanced blood flow can dissolve or partially or substantially dissolve the thrombus, and then the device-thrombotic complex. Is removed from the previously occluded site.

さらにまた別の実施形態において、本発明は閉塞された動脈内の血流を、血管から血栓の一部分または全てを溶解する効率を高め、装置の一部分を埋め込んで、回復させる方法及び装置に向けられる。この実施形態においては、装置が血栓の少なくとも一部分に絡み付き(あるいは埋め込まれるかまたは一体化して)、除去可能な、一体化された装置−血栓複合体を形成する。この除去可能な一体化された装置−血栓複合体が閉塞部位から取り出される。   In yet another embodiment, the present invention is directed to a method and apparatus for increasing the efficiency of lysing a portion or all of a thrombus from a blood vessel and implanting and recovering a portion of the device from a blood vessel in a blocked artery. . In this embodiment, the device is entangled (or embedded or integrated) with at least a portion of the thrombus to form an integrated device-thrombotic complex that can be removed. This removable integrated device-thrombotic complex is removed from the occlusion site.

いくつかの実施形態において、本発明の方法は血栓で閉塞されていた血管内の血流の回復を撮像するための方法に向けられる。本方法は、(a)血栓に径方向に隣接して配置された自動展開式装置の画像を取り込む工程及び(b)装置の展開及びこれによる血流の回復の画像を取り込む工程を含む。
別の実施形態において、本発明の方法は血管内に張り付いた血栓をある程度または実質的に溶解させる方法に向けられる。本方法は、a)血栓に径方向に隣接して配置された自
動展開式装置の画像を取り込む工程、及びb)装置の展開、およびそれによる血管を通る
血液の増大の画像を取り込む工程を包含し、増大した血流が、ある程度または実質的に血栓を溶解させる。
In some embodiments, the method of the invention is directed to a method for imaging recovery of blood flow in a blood vessel that has been occluded with a thrombus. The method includes (a) capturing an image of an automatically deployable device positioned radially adjacent to a thrombus, and (b) capturing an image of device deployment and resulting blood flow recovery.
In another embodiment, the method of the present invention is directed to a method of partially or substantially lysing thrombus stuck in a blood vessel. The method includes the steps of: a) capturing an image of a self-expanding device positioned radially adjacent to a thrombus, and b) capturing an image of deployment of the device and thereby blood growth through the blood vessel. However, the increased blood flow partially or substantially dissolves the thrombus.

さらにまた別の実施形態において、本発明の方法は血管内に張り付いた血栓の引剥しの撮像のための方法に向けられる。本方法は、(a)血栓に径方向に隣接して配置された自動展開式装置の画像を取り込む工程、(b)装置の展開及びこれによる血栓の少なくとも一部分への絡み付きの画像を取り込む工程及び(c)装置の遠位または近位への移動及びこれによる血栓の引剥しの画像を取り込む工程を含む。   In yet another embodiment, the method of the invention is directed to a method for imaging the removal of a thrombus stuck in a blood vessel. The method comprises (a) capturing an image of an automatically deployable device positioned radially adjacent to a thrombus, (b) capturing the image of the device deployed and thereby tangled to at least a portion of the thrombus, and (c) capturing the image of the distal or proximal movement of the device and the resulting removal of the thrombus.

数多くの自己展開式装置が本発明の方法に有用であると考えられる。一実施形態において、装置は可逆自動展開式である。別の実施形態において、装置は、完全に引戻しまたは引込みが可能である。一実施形態において、自動展開式装置は、第1の複数のメッシュセルをもつ、近端及び遠端を有する、メッシュ構造、第2の複数のメッシュセルをもつ、メッシュ構造の近端に向けて配置された、先細り部分、及び、先細り部分の近端に配置された、先細り部分が収斂する連結点を有し、装置は体積拡大形態をとるようにあらかじめ形成され、体積拡大形態において装置は連結点に向けて先細りになる軸方向開口管の形態をとる。   A number of self-expanding devices are believed useful in the method of the present invention. In one embodiment, the device is a reversible automatic deployment. In another embodiment, the device is fully retractable or retractable. In one embodiment, the self-expanding device has a first plurality of mesh cells, a near end and a far end, a mesh structure, a second plurality of mesh cells, toward the near end of the mesh structure. A tapered portion disposed and a connecting point disposed at a proximal end of the tapered portion where the tapered portion converges, wherein the device is pre-formed to take a volume expansion configuration, wherein the device is connected It takes the form of an axially open tube that tapers towards a point.

本発明の別の実施形態は、血管内の血栓の除去のための、第1の複数のメッシュセルをもつ、近端及び遠端を有し、遠端が血栓の少なくとも一部分に絡み付いて、除去可能な、一体化された装置−血栓複合体を形成するように適合された、メッシュ構造、第2の複数のメッシュセルをもつ、メッシュ構造の近端に向けて配置された、先細り部分、及び、先細り部分の近端に配置された、先細り部分が収斂する連結点を有する、自動展開式装置であり、装置は体積拡大形態をとるようにあらかじめ形成され、体積拡大形態において装置は連結点に向けて先細りになる軸方向開口管の形態をとる。   Another embodiment of the present invention has a proximal end and a distal end with a first plurality of mesh cells for removal of a thrombus in a blood vessel, the distal end entangled with at least a portion of the thrombus, and removal A mesh structure, adapted to form a possible integrated device-thrombosis complex, having a second plurality of mesh cells, disposed toward the proximal end of the mesh structure, and A self-expanding device having a connection point, which is arranged at the proximal end of the taper portion, where the taper portion converges, the device being pre-formed to take a volume expansion configuration, in which the device is at the connection point It takes the form of an axially open tube that tapers towards.

メッシュ構造の遠端は、メッシュ構造支持力を強めることにより、及び血栓保持力を強めることにより、血栓回収を補助するように構成されると考えられる。   The distal end of the mesh structure is believed to be configured to assist thrombus recovery by increasing the mesh structure support and by increasing the thrombus retention.

本発明の別の実施形態において、少なくとも一部分が装置に絡み付かれた血栓からなる、除去可能な、一体化された装置−血栓複合体が提供され、装置は、第1の複数のメッシュセルをもつ、近端及び遠端を有し、遠端が血栓の少なくとも一部分に絡み付くように構成された、メッシュ構造、第2の複数のメッシュセルをもつ、メッシュ構造の近端に向けて配置された、先細り部分、及び、先細り部分の近端に配置された、先細り部分が収斂する連結点を有し、装置は体積拡大形態をとるようにあらかじめ形成され、体積拡大形態において装置は連結点に向けて先細りになる軸方向開口管の形態をとる。   In another embodiment of the present invention, a removable, integrated device-thrombotic complex is provided, comprising at least a portion of a thrombus entangled with the device, the device comprising a first plurality of mesh cells. A mesh structure having a proximal end and a distal end, the distal end being configured to be entangled with at least a portion of the thrombus, and having a second plurality of mesh cells disposed toward the proximal end of the mesh structure A taper portion and a connection point disposed at a proximal end of the taper portion where the taper portion converges, wherein the device is pre-shaped to take a volume expansion configuration, wherein the device is directed to the connection point It takes the form of an axially open tube that tapers.

本発明はまた、以下の項目を提供する。
(項目1)血栓で閉塞された血管部位における局所血流を回復させる方法であって、上記方法は、
上記血栓に径方向に隣接する部位に、自動展開式装置を送り込む工程、および
上記装置を展開し、それによって血流を回復させる工程
を包含し、
上記装置は、
第1の複数のメッシュセルを含むメッシュ構造であって、上記メッシュ構造は、近端および遠端を有する、メッシュ構造と、
第2の複数のメッシュセルを含む先細り部分であって、上記先細り部分は、上記メッシュ構造の近端に向けて配置される、先細り部分と、
上記先細り部分が収斂する、上記先細り部分の近端に配置された、連結点と
を備え、上記装置は、体積拡大形態をとるようにあらかじめ形成され、上記体積拡大形態において上記連結点に向けて先細りになる、軸方向開放管の形態をとる、
方法。
(項目2)血管内に張り付いた血栓をある程度または実質的に溶解させる方法であって、上記方法は、
上記血栓に径方向に隣接する部位に、自動展開式装置を送り込む工程、および
上記装置を展開し、それによって上記血管を通る血液を増大させる工程
を包含し、上記増大した血流はある程度または実質的に上記血栓を溶解させ、
上記装置は、
第1の複数のメッシュセルを含むメッシュ構造であって、上記メッシュ構造は、近端および遠端を有する、メッシュ構造と、
第2の複数のメッシュセルを含む先細り部分であって、上記先細り部分は、上記メッシュ構造の近端に向けて配置される、先細り部分と、
上記先細り部分が収斂する、上記先細り部分の近端に配置された、連結点と
を備え、上記装置は、体積拡大形態をとるようにあらかじめ形成され、上記体積拡大形態において上記連結点に向けて先細りになる、軸方向開放管の形態をとる、
方法。
(項目3)
血管内に張り付いた血栓を引剥がす方法であって、上記方法は、
上記血栓に径方向に隣接する部位に、自動展開式装置を送り込む工程、
上記装置を、上記血栓の少なくとも一部分に絡み付くように展開する工程、および
上記装置を、近位に、または遠位に動かして、上記血栓を引剥がす工程
を包含し、
上記装置は、
第1の複数のメッシュセルを含むメッシュ構造であって、上記メッシュ構造は、近端および遠端を有する、メッシュ構造と、
第2の複数のメッシュセルを含む先細り部分であって、上記先細り部分は、上記メッシュ構造の近端に向けて配置される、先細り部分と、
上記先細り部分が収斂する、上記先細り部分の近端に配置された、連結点と
を備え、上記装置は、体積拡大形態をとるようにあらかじめ形成され、上記体積拡大形態において上記連結点に向けて先細りになる、軸方向開放管の形態をとる、
方法。
(項目4)上記装置が、可逆自動展開式である、上記項目のいずれか1項に記載の方法。
(項目5)上記装置が、近端および遠端を有する送り込みデバイスによって送り込まれる、上記項目のいずれか1項に記載の方法。
(項目6)上記装置が、上記送り込みデバイス内に含まれている間は展開されない、項目5に記載の方法。
(項目7)上記装置が、上記送り込みデバイスを近位に、かつ/または上記装置を遠位に動かすことによって、展開される、項目6に記載の方法。
(項目8)上記連結点は押出ワイヤに固定される、上記項目のいずれか1項に記載の方法。
(項目9)上記装置は、上記押出ワイヤを遠位に動かすことによって展開され得る、項目8に記載の方法。
(項目10)上記送り込みデバイスは、上記血栓に径方向に隣接するように配置される、項目5に記載の方法。
(項目11)上記送り込みデバイスの遠端は、上記血栓に対して遠位にある、項目10に記載の方法。
(項目12)上記送り込みデバイスは近位に動かされ、それによって上記装置が上記血栓に径方向に隣接するように上記装置が展開される、項目9に記載の方法。
(項目13)上記血栓に、有効量の血塊退治薬剤を送り込む工程をさらに包含する、上記項目のいずれか1項に記載の方法。
(項目14)項目3に記載の方法であって、さらに上記血栓を上記血管から除去する工程を包含する、項目3に記載の方法。
(項目15)上記自動展開式装置は、上記血栓に対して遠位に送り込まれる、項目14に記載の方法。
(項目16)上記メッシュ構造の遠端は、上記血栓の少なくとも一部分に絡みつき、除去可能な、一体化された装置−血栓複合体を形成するように構成されている、項目15に記載の方法。
(項目17)上記除去可能な、一体化された装置−血栓複合体は、上記血管を通して近位に動かされる、項目16に記載の方法。
(項目18)上記除去可能な、一体化された装置−血栓複合体は、上記血管から引き出される、項目17に記載の方法。
(項目19)上記装置は、上記血管における血流を回復させるのに十分な時間、展開される、上記項目のいずれか1項に記載の方法。
(項目20)血栓で閉塞された血管における血流の回復の撮像のための方法であって、該方法は、
a)血栓に径方向に隣接して配置された自動展開式装置の画像を取り込む工程、及び
b)上記装置の展開、およびそれによる血流の回復の画像を取り込む工程を包含する、方法。
(項目21)血管内に張り付いた血栓をある程度または実質的に溶解させる方法であって、上記方法は、
a)血栓に径方向に隣接して配置された自動展開式装置の画像を取り込む工程、及び
b)上記装置の展開、およびそれによる上記血管を通る血液の増大の画像を取り込む工程
を包含し、増大した血流が、ある程度または実質的に上記血栓を溶解させる、方法。
(項目22)血管内に張り付いた血栓の引剥がしの撮像のための方法であって、上記方法は、
a)血栓に径方向に隣接して配置された自動展開式装置の画像を取り込む工程、
b)上記装置の展開、およびそれによる上記血栓の少なくとも一部分への絡み付きの画像を取り込む工程、および
c)上記装置の遠位または近位への移動、およびそれによる上記血栓の引剥がしの画像を取り込む工程
を包含する、方法。
(項目23)
血管内の血栓の除去のための自動展開式装置であって、
第1の複数のメッシュセルを有するメッシュ構造であって、上記メッシュ構造が近端及び遠端を有し、上記メッシュ構造の上記遠端が上記血栓の少なくとも一部分に絡み付いて除去可能な一体化された装置−血栓複合体を形成するように構成された、メッシュ構造、
第2の複数のメッシュ構造を有する先細り部分であって、上記先細り部分が上記メッシュ構造の上記近端に向けて配置される、先細り部分、及び
上記先細り部分が収斂する、上記先細り部分の近端に配置された、連結点、
を有し、
上記装置が、体積拡大形態をとるようにあらかじめ形成され、上記体積拡大形態において上記連結点に向けて先細りになる、軸方向開放管の形態をとる、
ことを特徴とする装置。
(項目24)
上記メッシュ構造の上記遠端がコイルまたはアイレットの形状をもつX線不透過性マーカーを有することを特徴とする項目23に記載の装置。
(項目25)
上記メッシュ構造の上記遠端が、上記体積拡大形態において上記体積拡大形態における上記メッシュ構造の上記近端より大きな直径を有することを特徴とする項目23に記載の装置。
(項目26)
上記メッシュ構造の上記遠端が第3の複数のメッシュセルを有し、上記第3の複数のメッシュセルが上記第2の複数のメッシュセルより小さいセル寸法を有することを特徴とする項目23に記載の装置。
(項目27)
上記メッシュ構造の上記遠端が1つ以上のペグ及び/またはフックを有することを特徴とする項目23に記載の装置。
(項目28)
上記メッシュ構造の上記遠端がファイバを有することを特徴とする項目23に記載の装置。
(項目29)
上記メッシュ構造の上記遠端が強められた径方向力を与えるに十分な時間加熱されることを特徴とする項目23に記載の装置。
(項目30)
上記メッシュ構造が抗血液凝固性または抗血小板性の薬剤でコーティングされることを特徴とする項目23に記載の装置。
(項目31)
上記メッシュ構造がさらに生分解性/生体適合性の高分子材でコーティングされて上記抗血液凝固性または抗血小板性の薬剤の徐放を提供することを特徴とする項目30に記載の装置。
(項目32)
上記メッシュ構造が抗血液凝固性または抗血小板性の薬剤を保持するための貯槽を有することを特徴とする項目23に記載の装置。
(項目33)
装置に少なくともある程度絡み付かれた血栓を有する除去可能な一体化された装置−血栓複合体であって、上記装置が、
第1の複数のメッシュセルを有するメッシュ構造であって、上記メッシュ構造が近端及び遠端を有し、上記メッシュ構造の上記遠端が上記血栓の少なくとも一部分に絡み付くように構成された、メッシュ構造、
第2の複数のメッシュ構造を有する先細り部分であって、上記先細り部分が上記メッシュ構造の上記近端に向けて配置される、先細り部分、及び
上記先細り部分が収斂する、上記先細り部分の近端に配置された、連結点、
を有し、
上記装置が、体積拡大形態をとるようにあらかじめ形成され、上記体積拡大形態において上記連結点に向けて先細りになる、軸方向開放管の形態をとる、
ことを特徴とする装置−血栓複合体。
本明細書に組み込まれて本明細書の一部をなす添付図面は、本発明の例示的実施形態を示し、上で与えられた全般的説明及び以下に与えられる詳細な説明とともに本発明の特徴の説明に役立つ。
The present invention also provides the following items.
(Item 1) A method for restoring local blood flow in a blood vessel site blocked by a thrombus, the method comprising the steps of:
Including a step of feeding an automatic deployment device to a site radially adjacent to the thrombus, and a step of deploying the device, thereby restoring blood flow,
The above device
A mesh structure including a first plurality of mesh cells, the mesh structure having a near end and a far end;
A tapered portion including a second plurality of mesh cells, wherein the tapered portion is disposed toward a proximal end of the mesh structure; and
A connecting point disposed at a proximal end of the tapered portion, wherein the tapered portion converges, wherein the device is pre-formed to take a volume expansion configuration, and toward the connection point in the volume expansion configuration. Tapering, taking the form of an axially open tube,
Method.
(Item 2) A method for dissolving a thrombus stuck in a blood vessel to some extent or substantially, the method comprising:
Delivering a self-expanding device to a site radially adjacent to the thrombus, and deploying the device, thereby increasing blood through the blood vessel, the increased blood flow to some extent or substantially To dissolve the thrombus,
The above device
A mesh structure including a first plurality of mesh cells, the mesh structure having a near end and a far end;
A tapered portion including a second plurality of mesh cells, wherein the tapered portion is disposed toward a proximal end of the mesh structure; and
A connecting point disposed at a proximal end of the tapered portion, wherein the tapered portion converges, wherein the device is pre-formed to take a volume expansion configuration, and toward the connection point in the volume expansion configuration. Tapering, taking the form of an axially open tube,
Method.
(Item 3)
A method of peeling a blood clot stuck in a blood vessel,
A step of feeding an automatic deployment device to a site radially adjacent to the thrombus,
Deploying the device to entangle with at least a portion of the thrombus, and moving the device proximally or distally to tear off the thrombus;
The above device
A mesh structure including a first plurality of mesh cells, the mesh structure having a near end and a far end;
A tapered portion including a second plurality of mesh cells, wherein the tapered portion is disposed toward a proximal end of the mesh structure; and
A connecting point disposed at a proximal end of the tapered portion, wherein the tapered portion converges, wherein the device is pre-formed to take a volume expansion configuration, and toward the connection point in the volume expansion configuration. Tapering, taking the form of an axially open tube,
Method.
(Item 4) The method according to any one of the above items, wherein the device is a reversible automatic deployment type.
(Item 5) A method according to any one of the preceding items, wherein the apparatus is fed by a feeding device having a near end and a far end.
6. The method of claim 5, wherein the device is not deployed while it is included in the delivery device.
7. The method of claim 6, wherein the device is deployed by moving the delivery device proximally and / or the device distally.
(Item 8) The method according to any one of the above items, wherein the connection point is fixed to an extruded wire.
9. The method of claim 8, wherein the device can be deployed by moving the extrusion wire distally.
(Item 10) The method according to item 5, wherein the delivery device is arranged to be radially adjacent to the thrombus.
11. The method of claim 10, wherein the distal end of the delivery device is distal to the thrombus.
12. The method of claim 9, wherein the delivery device is moved proximally, thereby deploying the device such that the device is radially adjacent to the thrombus.
(Item 13) The method according to any one of the above items, further comprising a step of feeding an effective amount of a clot-extinguishing agent into the thrombus.
(Item 14) The method according to item 3, further comprising the step of removing the thrombus from the blood vessel.
15. The method of claim 14, wherein the self-deploying device is delivered distal to the thrombus.
16. The method of claim 15, wherein the far end of the mesh structure is configured to entangle with and remove at least a portion of the thrombus to form an integrated device-thrombotic complex.
17. The method of claim 16, wherein the removable, integrated device-thrombotic complex is moved proximally through the blood vessel.
18. The method of claim 17, wherein the removable, integrated device-thrombotic complex is withdrawn from the blood vessel.
(Item 19) The method according to any one of the preceding items, wherein the device is deployed for a time sufficient to restore blood flow in the blood vessel.
(Item 20) A method for imaging blood flow recovery in a blood vessel occluded by a thrombus, the method comprising:
a) capturing an image of a self-expanding device positioned radially adjacent to a thrombus, and b) capturing an image of deployment of the device and resulting blood flow recovery.
(Item 21) A method for dissolving a thrombus stuck in a blood vessel to some extent or substantially, the method comprising:
a) capturing an image of a self-expanding device positioned radially adjacent to a thrombus, and b) capturing an image of deployment of the device and thereby blood growth through the blood vessel, A method wherein increased blood flow dissolves the thrombus to some extent or substantially.
(Item 22) A method for imaging of detachment of a thrombus stuck in a blood vessel, the method comprising:
a) capturing an image of an automatically deployable device positioned radially adjacent to the thrombus,
b) capturing the image of deployment of the device and thereby tangling to at least a portion of the thrombus, and c) image of distal or proximal movement of the device and thereby tearing off the thrombus. A method comprising the step of incorporating.
(Item 23)
An automatically deployable device for removal of blood clots in blood vessels,
A mesh structure having a first plurality of mesh cells, wherein the mesh structure has a near end and a far end, and the far end of the mesh structure is entangled and removed from at least a portion of the thrombus. A mesh structure, configured to form a device-thrombotic complex,
A tapered portion having a second plurality of mesh structures, wherein the tapered portion is disposed toward the proximal end of the mesh structure, and the tapered portion is converged by the tapered portion. A connection point, located at
Have
The device is in the form of an axially open tube that is pre-formed to take a volume expansion configuration and tapers toward the connection point in the volume expansion configuration;
A device characterized by that.
(Item 24)
24. The apparatus according to item 23, wherein the far end of the mesh structure has a radiopaque marker having a coil or eyelet shape.
(Item 25)
24. The apparatus of item 23, wherein the far end of the mesh structure has a larger diameter in the volume expansion configuration than the near end of the mesh structure in the volume expansion configuration.
(Item 26)
Item 23 is characterized in that the far end of the mesh structure has a third plurality of mesh cells, and the third plurality of mesh cells has a smaller cell size than the second plurality of mesh cells. The device described.
(Item 27)
24. Apparatus according to item 23, wherein the far end of the mesh structure has one or more pegs and / or hooks.
(Item 28)
Item 24. The apparatus of item 23, wherein the far end of the mesh structure comprises a fiber.
(Item 29)
Item 24. The apparatus of item 23, wherein the far end of the mesh structure is heated for a time sufficient to provide an enhanced radial force.
(Item 30)
Item 24. The device according to Item 23, wherein the mesh structure is coated with an anticoagulant or antiplatelet agent.
(Item 31)
Item 31. The device according to Item 30, wherein the mesh structure is further coated with a biodegradable / biocompatible polymer material to provide sustained release of the anticoagulant or antiplatelet agent.
(Item 32)
Item 24. The apparatus according to Item 23, wherein the mesh structure has a reservoir for holding an anticoagulant or antiplatelet agent.
(Item 33)
A removable integrated device-thrombotic complex having a thrombus at least partially entangled with the device, the device comprising:
A mesh structure having a first plurality of mesh cells, wherein the mesh structure has a near end and a far end, and the far end of the mesh structure is configured to be entangled with at least a portion of the thrombus. Construction,
A tapered portion having a second plurality of mesh structures, wherein the tapered portion is disposed toward the proximal end of the mesh structure, and the tapered portion is converged by the tapered portion. A connection point, located at
Have
The device is in the form of an axially open tube that is pre-formed to take a volume expansion configuration and tapers toward the connection point in the volume expansion configuration;
A device-thrombotic complex characterized by the above.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention, and together with the general description given above and the detailed description given below, are features of the invention. Useful for explaining.

図1は本発明の方法に有用な装置を示す。FIG. 1 shows an apparatus useful for the method of the present invention. 図2aは、本発明によって処置されることになる、標的の閉塞または血栓を示す。FIG. 2a shows a target occlusion or thrombus to be treated according to the present invention. 図2bは本発明にしたがう配置方法を示す。FIG. 2b shows a placement method according to the present invention. 図3は本発明にしたがう配置方法を示し、マイクロカテーテル8が隠れ線で示される。FIG. 3 shows a placement method according to the present invention, with the microcatheter 8 shown in hidden lines. 図4は本発明にしたがう配置方法を示す。FIG. 4 shows an arrangement method according to the present invention. 図5は本発明にしたがう血栓の引剥し及び可動化を示す。FIG. 5 illustrates thrombus detachment and mobilization according to the present invention. 図6は本発明にしたがう血栓溶解方法を示す。FIG. 6 shows a thrombolysis method according to the present invention. 図7は本発明にしたがう血栓溶解方法を示す。FIG. 7 illustrates a thrombolysis method according to the present invention. 図8は本発明にしたがう装置引戻し方法を示し、マイクロカテーテルが隠れ線で示される。FIG. 8 shows a device pullback method according to the present invention, with the microcatheter shown in hidden lines. 図9は本発明にしたがう装置引戻し方法を示し、マイクロカテーテルが隠れ線で示される。FIG. 9 shows a device pullback method according to the present invention, with the microcatheter shown in hidden lines. 図10は本発明にしたがう装置埋込方法を示す。FIG. 10 illustrates a device embedding method according to the present invention. 図11は本発明にしたがう装置埋込方法を示す。FIG. 11 illustrates a device embedding method according to the present invention. 図12は本発明にしたがう装置埋込方法を示す。FIG. 12 illustrates a device embedding method according to the present invention. 図13は、ハニカム構造を有する、本発明の一実施形態にしたがう装置である。FIG. 13 is an apparatus according to an embodiment of the present invention having a honeycomb structure. 図14は、ハニカム構造を有する、本発明にしたがうステントの別の実施形態である。FIG. 14 is another embodiment of a stent according to the present invention having a honeycomb structure. 図15は、ハニカム構造を有する、本発明にしたがうステントの第3の実施形態である。FIG. 15 is a third embodiment of a stent according to the present invention having a honeycomb structure. 図16は本発明にしたがう装置に用いることができるような縦編み構造である。FIG. 16 shows a warp knitting structure that can be used in an apparatus according to the present invention. 図17aは本発明の一実施形態にしたがう装置の略図であり、装置は重畳形状で示される。FIG. 17a is a schematic diagram of an apparatus according to an embodiment of the present invention, the apparatus being shown in a superimposed shape. 図17bは本発明の一実施形態にしたがう装置の略図であり、装置は体積縮小形状で示される。FIG. 17b is a schematic diagram of an apparatus according to an embodiment of the present invention, the apparatus being shown in a reduced volume configuration. 図18aは、本発明にしたがう装置の最遠位セグメントに用いることができる、マーカー素子を有する実施形態である。FIG. 18a is an embodiment having a marker element that can be used in the most distal segment of a device according to the present invention. 図18bは、本発明にしたがう装置の最遠位セグメントに用いることができる、マーカー素子を有する実施形態である。FIG. 18b is an embodiment with a marker element that can be used in the most distal segment of a device according to the present invention. 図18cは、本発明にしたがう装置の最遠位セグメントに用いることができる、マーカー素子を有する実施形態である。FIG. 18c is an embodiment having a marker element that can be used in the most distal segment of a device according to the present invention. 図18dは、本発明にしたがう装置の最遠位セグメントに用いることができる、マーカー素子を有する実施形態である。FIG. 18d is an embodiment having a marker element that can be used in the most distal segment of a device according to the present invention. 図18eは、本発明にしたがう装置の最遠位セグメントに用いることができる、マーカー素子を有する実施形態である。FIG. 18e is an embodiment having a marker element that can be used in the most distal segment of a device according to the present invention. 図19aは、本発明にしたがう装置を誘導ワイアに取外し可能な態様で連結することができる、取外し場所の略図である。FIG. 19a is a schematic illustration of a removal location where a device according to the present invention can be removably coupled to a guide wire. 図19bは、本発明にしたがう装置を誘導ワイアに取外し可能な態様で連結することができる、図19aとは異なる、取外し場所の略図である。FIG. 19b is a schematic illustration of a removal location, as opposed to FIG. 19a, in which a device according to the present invention can be removably coupled to a guide wire.

別途に定義されない限り、本明細書に用いられる技術用語及び科学用語は全て本発明が属する技術分野の当業者によって普通に理解される意味と同じ意味を有する。本明細書に説明される方法及び材料と同様であるかまたは等価ないかなる方法及び材料も本発明の実施または試験に用いられ得るが、好ましい方法、デバイス及び材料がここで説明される。本明細書に引用される刊行物及び特許出願明細書は全て、それぞれの全体が本明細書に参照として含まれる。本明細書における引用のいずれも、先行発明によるそのような開示よりも先願である資格が本発明に与えられないことの自認と解されるべきではない。   Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods, devices and materials are now described. All publications and patent application specifications cited in this specification are hereby incorporated by reference in their entirety. None of the citations herein should be construed as an admission that the invention is not entitled to antedate earlier than such disclosure by the prior invention.

本明細書に及び添付される特許請求の範囲に用いられるように、単数形の冠詞,‘a’,‘an’及び‘the’は、そうではないことが別に明白に規定されていない限り、複数の
指示対象を含むことに注意しなければならない。
As used herein and in the appended claims, the singular articles 'a', 'an' and 'the', unless expressly specified otherwise, It should be noted that it includes multiple indication objects.

方法
発明は閉塞された血管部位に局所血流を回復させる方法に向けられる。血管部位、すなわち血管は、血栓によって閉塞され得る。本発明の方法に用いられる装置は、マイクロカテーテル及び、必要に応じて、誘導カテーテルにより、血管部位に配置することができる。本発明の方法は完全に引戻し可能な装置を用いることができ、これは方法が永久的に患者に埋め込まれる装置を必要とする技術に優る改善である。装置が永久的に患者に埋め込まれる場合、患者には生涯続く抗血液凝固治療が必要となる。したがって、引き戻し可能な装置を用いることで、生涯続く抗血液凝固治療を回避できると考えられる。
The method invention is directed to a method of restoring local blood flow to a blocked vascular site. A vascular site, or blood vessel, can be occluded by a thrombus. The device used in the method of the present invention can be placed in a blood vessel site by a microcatheter and, if necessary, a guiding catheter. The method of the present invention can use a fully retractable device, which is an improvement over techniques that require the device to be permanently implanted in the patient. If the device is permanently implanted in the patient, the patient needs lifelong anticoagulant therapy. Therefore, it is considered that anti-coagulation treatment that lasts for a lifetime can be avoided by using a retractable device.

血栓12(図2a)で閉塞された大脳動脈11において血流を回復させるための方法及び装置が提供される。そのような方法は、遠端2,近端3及び本体部分4を有する、自動展開可能であり、必要に応じて可逆自動展開可能である、遠位セグメント1を有し、本体部分4は、非拘束状態では重畳構造5をとるようにあらかじめ形成されるが、近端3及びマイクロカテーテル8に取り付けられた押出ワイア7による送込みを可能にする体積縮小形態6をとるようにすることができ、遠位セグメント1は重畳構造5において軸方向開放管の形態をとり、相互接続されたストリングまたはフィラメントまたは支材からなるメッシュ構造を有する(図1及び3)。一実施形態において、遠位セグメント1は、ストリングまたはフィラメントまたは支材が連結点9で収斂する、近端3において先細り構造を有する。押出ワイア7は連結点9にまたは連結点9に隣接して取り付けられることが好ましい。そのような取付機構10は永久的であるかまたは取外し可能な機構とすることができる。本明細書に開示される方法は、米国特許第7300458号明細書に説明される医用遠位セグメント1(または装置またはステント:これらの用語は全て互換で用いられる)によって実施することができる。この特許明細書はその全体が本明細書に参照として含まれる。   A method and apparatus is provided for restoring blood flow in a cerebral artery 11 occluded with a thrombus 12 (FIG. 2a). Such a method has a distal segment 1 having a distal end 2, a proximal end 3 and a body portion 4 that is self-expandable and reversibly self-expandable as required. In the unconstrained state, it is formed in advance so as to take the overlapping structure 5, but it can take a volume reduction form 6 that enables feeding by the pusher wire 7 attached to the proximal end 3 and the microcatheter 8. The distal segment 1 takes the form of an axially open tube in a superimposed structure 5 and has a mesh structure made of interconnected strings or filaments or struts (FIGS. 1 and 3). In one embodiment, the distal segment 1 has a tapered structure at the proximal end 3 where the strings or filaments or struts converge at the connection point 9. The extrusion wire 7 is preferably mounted at or adjacent to the connection point 9. Such an attachment mechanism 10 can be a permanent or removable mechanism. The methods disclosed herein can be performed by the medical distal segment 1 (or device or stent: these terms are used interchangeably) described in US Pat. No. 7,300,498. This patent specification is hereby incorporated by reference in its entirety.

本発明にしたがえば、装置の自動展開式遠位セグメント1は血栓12で閉塞された血管11内に、近端3が血栓の上流側にあり、遠端2が血栓の下流側にあって、本体部分4が血栓12に径方向に隣接して配置されるように、マイクロカテーテル8内の押出ワイア7で前進させることによって体積縮小形態6で配置される(図1及び3)。図3に示されるように、遠位セグメント1の遠端2は血栓の遠位境界より遠位に配置され、遠位セグメントの近端3は血栓の近位境界より近位に配置される。遠位セグメント1は押出ワイア7を静止させておくことによって固定位置に保持されるが、遠位セグメント1はマイクロカテーテル8を遠位セグメント1より手前に引き戻すことによって体積縮小形態6から解放される(図4)。遠位セグメント1は非拘束状態13において少なくとも一部分が重畳構造5をとり、よって、展開して本体部分の少なくとも一部分を血栓12'に侵入接触させ、血栓
12'に径方向に外向きの力をかけて血栓12'の断面積を縮小させ、即時に、血栓12'
を抜けて血管11を流過する血流14を回復させる。
In accordance with the present invention, the self-expanding distal segment 1 of the device is in a blood vessel 11 occluded with a thrombus 12, the proximal end 3 is upstream of the thrombus and the distal end 2 is downstream of the thrombus. The body portion 4 is placed in a volume-reduced configuration 6 by advancing with an extrusion wire 7 in the microcatheter 8 so that the body portion 4 is placed radially adjacent to the thrombus 12 (FIGS. 1 and 3). As shown in FIG. 3, the distal end 2 of the distal segment 1 is disposed distal to the distal boundary of the thrombus, and the proximal end 3 of the distal segment is disposed proximal to the proximal boundary of the thrombus. The distal segment 1 is held in a fixed position by keeping the pusher wire 7 stationary, while the distal segment 1 is released from the volume reduction configuration 6 by pulling the microcatheter 8 back towards the distal segment 1. (Figure 4). The distal segment 1 has at least a portion of the overlapping structure 5 in the unconstrained state 13 so that it deploys and causes at least a portion of the body portion to enter and contact the thrombus 12 ′ and exert a radially outward force on the thrombus 12 ′. To reduce the cross-sectional area of the thrombus 12 'and immediately
The blood flow 14 passing through the blood vessel 11 through the blood vessel 11 is recovered.

血栓の部位に、例えば組織プラスミノーゲン賦活剤(tPA)のような、血塊退治薬剤の有効量の投与も本発明によって考えられる。この薬剤の投与は血塊の溶解をさらに強めるように作用するであろう。   Administration of an effective amount of a clot-killing agent, such as tissue plasminogen activator (tPA), for example, to the thrombus site is also contemplated by the present invention. Administration of this drug will act to further enhance clot lysis.

この配置方法により、本発明の方法は遠位セグメント1を血栓12の遠端より先方に配置するから、マイクロカテーテルの到達距離より遠位の脈管内空間を必要とする装置を通した処置が望ましい患者の人口が拡大する。さらに、この配置方法により、ユーザが既に習熟しているマイクロカテーテル技術を用いて装置を送り込むことができ、装置の迅速な配置が容易になるから、方法を成功裏に実施することができる医師の人口が拡大する。血流14の即時回復は血栓12で閉塞された大脳動脈11の処置に対して、既知の装置及び方法では血流14の回復に数時間かかり得るし、神経学的永久欠損のリスク及び程度は症状発生から血流回復までの時間が長くなるとともに急速に高くなることが十分確立されているから、既知の装置及び方法に優る重要な利点である。   Because of this placement method, the method of the present invention places the distal segment 1 ahead of the distal end of the thrombus 12, so treatment through a device requiring an intravascular space distal to the reach of the microcatheter is desirable. The patient population expands. In addition, this placement method allows the device to be fed using microcatheter technology that the user is already familiar with, and facilitates rapid placement of the device, so that the physician can successfully implement the method. Population expands. Immediate recovery of blood flow 14 may take several hours to recover blood flow 14 with known devices and methods versus treatment of cerebral artery 11 occluded with thrombus 12, and the risk and extent of neurological permanent defects is It is an important advantage over known devices and methods since it is well established that the time from symptom onset to blood flow recovery is long and increases rapidly.

一実施形態において、血管からの血栓12'の引剥しを血栓12'及び装置の患者からの取出しと合わせて高められた効率で閉塞された動脈11において血流を回復させる、血栓除去方法及び装置が提供される。好ましい実施形態において、閉塞された動脈11において血流14を回復させる工程は、マイクロカテーテル8の遠位先端16が血栓12の遠端より先になるようにマイクロカテーテルを配置する工程を含み、遠位先端16は血栓12の遠端より、約0mmより大きく約10mmないしさらに先まで、あるいは約3mmから約5mmまで(図2b)にある。自動展開式遠位セグメント1は、体積縮小形態6でマイクロカテーテル8内を押出ワイア7によって遠端2が血栓12の遠端をちょうどこえるまで進められる(図3)。   In one embodiment, a thrombectomy method and apparatus that restores blood flow in an artery 11 that is occluded with increased efficiency combined with removal of the thrombus 12 'from the blood vessel in conjunction with removal of the thrombus 12' and the device from the patient. Is provided. In a preferred embodiment, restoring the blood flow 14 in the occluded artery 11 includes positioning the microcatheter so that the distal tip 16 of the microcatheter 8 is ahead of the distal end of the thrombus 12, The distal tip 16 is greater than about 0 mm and about 10 mm to further from the distal end of the thrombus 12 or from about 3 mm to about 5 mm (FIG. 2 b). The self-expanding distal segment 1 is advanced through the microcatheter 8 in volume-reduced configuration 6 by the pusher wire 7 until the distal end 2 just exceeds the distal end of the thrombus 12 (FIG. 3).

適切な配置の可視化はX線透視法によって行うことができる。特に、これは遠位セグメントの遠端上のX線不透過性マーカー15をX線不透過性マイクロカテーテル遠位マーカー17と位置合せすることによって達成することができる(図3)。上述したように、本発明はプロセスの画像を取り込む様々な方法にも向けられる。一般に用いられる撮像方法は、(装置の適切な配置を確認できる)X線透視法または(血流回復を確認できる)造影剤注入法である。しかし、当業者には既知の数多くの撮像方法も考えられる。   Appropriate placement visualization can be done by fluoroscopy. In particular, this can be accomplished by aligning radiopaque marker 15 on the distal end of the distal segment with radiopaque microcatheter distal marker 17 (FIG. 3). As mentioned above, the present invention is also directed to various methods for capturing an image of a process. Commonly used imaging methods are fluoroscopy (which can confirm proper placement of the device) or contrast agent injection (which can confirm blood flow recovery). However, many imaging methods known to those skilled in the art are also conceivable.

次いで、遠位セグメント1が解放された非拘束状態13になるまで、押出ワイア7を固定したままマイクロカテーテル8を手前に引き戻すことによって、遠位セグメント1が血栓12'内にまた血栓12'にわたって展開される(図4)。完全展開の一指標は、遠位セグメント1の近端3を定めるX線不透過性マーカー18がX線不透過性マイクロカテーテル遠位マーカー17と、またはその遠端と、位置合せされたこと診療医による視認である。あるいは、患者からマイクロカテーテル8を完全に取り出すことができる。遠位セグメント1が展開されて非拘束状態13になると直ちに、血栓12'にかけて血流14が回復さ
れ、造影剤注入によって回復確認を視認することができる。これは血栓12'及び解剖学
的血管構造に対する適切な遠位セグメント位置の指標である。
The distal segment 1 is then pulled into the thrombus 12 'and across the thrombus 12' by pulling the microcatheter 8 forward with the pusher wire 7 secured until the distal segment 1 is in the released unrestrained state 13. Expanded (FIG. 4). One indicator of full deployment is that the radiopaque marker 18 defining the proximal end 3 of the distal segment 1 is aligned with the radiopaque microcatheter distal marker 17 or with its distal end. Visual inspection by a doctor. Alternatively, the microcatheter 8 can be completely removed from the patient. As soon as the distal segment 1 is deployed into the unrestrained state 13, the blood flow 14 is restored over the thrombus 12 ′, and the recovery confirmation can be visually recognized by contrast medium injection. This is an indication of the proper distal segment position for the thrombus 12 'and anatomical vasculature.

本装置は、約0分から約120分ないしさらに長くすることができる遠位セグメント1の拘束状態13への展開後の定められた時間の経過、血栓12'にわたる血流14の停止
の観測、あらかじめ定められた最大血流維持時間の経過の、いずれが最初におきるとしても、その1つの後に、血栓12'を除去するために用いることができる。
The device provides a predetermined time course after deployment of the distal segment 1 to the constrained state 13 that can be from about 0 minutes to about 120 minutes or longer, observation of the cessation of blood flow 14 across the thrombus 12 ′, Any one of the defined maximum blood flow maintenance time passes, whichever occurs first, can be used to remove the thrombus 12 '.

血栓12'の除去は多くの様々な変形形態のいずれかによって達成することができる(図5)。例えば、体積縮小形態6の遠位先端は血栓の先に移動されるから、展開に対して受
ける抵抗が小さくなり、図5に示されるように血栓に絡み付いている部分に比べて、径方向に一層大きな力を与えるであろう。すなわち、遠位先端2は血栓12'の先で展開して
血栓の少なくとも一部分に絡み付かれている遠位セグメントの直径より大きな直径を有する遠位先端2を形成することができる。いくつかの実施形態において、これはフック様遠位形状とすることができる。血栓への絡み付き及び血栓除去にさらに役立たせるために用いることができるであろう別の構造改変が以下で説明される。押出ワイア7を用いれば、展開されて非拘束状態13にある遠位セグメント1を引っ張る力19が、フック様形状が血栓を捕らえるように作用するから、血栓をカテーテル内に引き込むであろう。その後のカテーテルの取出しの結果、閉塞部位から血栓が除去されるであろう。
Removal of the thrombus 12 ′ can be achieved by any of a number of different variations (FIG. 5). For example, since the distal tip of the volume-reduced form 6 is moved to the tip of the thrombus, the resistance to the deployment is reduced, and compared to the portion entangled with the thrombus as shown in FIG. It will give more power. That is, the distal tip 2 can be deployed beyond the thrombus 12 'to form a distal tip 2 having a diameter that is greater than the diameter of the distal segment that is entangled with at least a portion of the thrombus. In some embodiments, this can be a hook-like distal shape. Other structural modifications that may be used to further aid in thrombotic entanglement and thrombus removal are described below. With the pusher wire 7, the force 19 that pulls the distal segment 1 in the unconstrained state 13 deployed will draw the thrombus into the catheter because the hook-like shape acts to catch the thrombus. Subsequent removal of the catheter will result in removal of the thrombus from the occluded site.

装置を引き戻す前に、以下のいずれかの態様でマイクロカテーテル8を操作することができる:
X線不透過性マイクロカテーテル遠位マーカー17をX線不透過性遠位セグメント近端マーカー18にまたはその近傍に残すことができ、あるいは患者から完全に取り出すことができる;
遠位セグメント1に対するあらかじめ定められた位置までマイクロカテーテル8を前進させることができ、これは、X線不透過性マイクロカテーテル遠位マーカー17がX線不透過性遠位セグメント近端マーカー18と所望通りに位置合せされた場合、X線不透過性マイクロカテーテル遠位マーカー17がX線不透過性遠位セグメント近端マーカー18の遠端と所望通りに、例えば約0.5mmから約10mmまたは約5mmから約10mmの
範囲で、位置合せされた場合、マイクロカテーテル8の座屈によって明らかになるようにマイクロカテーテル8の前進に対してかなりの抵抗を受けた場合の、所望の位置合わせまたはかなりの抵抗のいずれが初めにおころうとも、その場合とすることができる。展開されて非拘束状態13にある遠位セグメント1を誘導カテーテルに向けてまたは誘導カテーテル内に移動させている間、以下のいずれかがおこり得る:
誘導カテーテル内腔近端が加圧バッグまたはその他の陽圧流体源と通じる;または
誘導カテーテル内腔近端が吸引源またはその他の陰圧源と通じる。
Prior to pulling the device back, the microcatheter 8 can be manipulated in any of the following ways:
Radiopaque microcatheter distal marker 17 can be left at or near radiopaque distal segment proximal end marker 18 or can be completely removed from the patient;
The microcatheter 8 can be advanced to a predetermined position relative to the distal segment 1 so that the radiopaque microcatheter distal marker 17 is desired with the radiopaque distal segment proximal end marker 18. When aligned on the street, the radiopaque microcatheter distal marker 17 and the distal end of the radiopaque distal segment proximal end marker 18 as desired, for example from about 0.5 mm to about 10 mm or about When aligned in the range of 5 mm to about 10 mm, the desired alignment or substantial amount when subjected to significant resistance to advancement of the microcatheter 8 as evidenced by the buckling of the microcatheter 8 Whichever of the resistors occurs first can be the case. While moving the distal segment 1 deployed and unrestrained 13 toward or into the guide catheter, one of the following may occur:
The proximal end of the guiding catheter lumen communicates with a pressurized bag or other positive pressure fluid source; or the proximal end of the guiding catheter lumen communicates with an aspiration source or other negative pressure source.

本発明の血栓除去方法は既知の血栓除去方法に優る独特の利点を有する。血栓にかけて展開されたときに、遠位セグメント1は血栓12'にかけて流路を形成する(図4)ことによって内部処置による血流14を生じさせる。このようにすれば、非拘束状態13にある遠位セグメント1は血栓12'にかけての圧力降下をかなり小さくし、したがって、そうでなければ血栓12の除去に抵抗するであろう圧力をかなり下げる(図5)。さらに、展開されて非拘束状態13にある遠位セグメント1が血栓12'の周縁のかなりの部分を血管壁から引き離すことによって流路が形成される。加えて、体積縮小形態6の展開が、血栓内にメッシュが埋め込まれている、一体化された複合体を形成する。上述したように、体積縮小形態6の遠位部分は大きな径方向力を発生することができ(また展開時にフック様形状をとることができ)、よって血栓の除去を容易にすることができる。   The thrombus removal method of the present invention has unique advantages over known thrombus removal methods. When deployed over the thrombus, the distal segment 1 creates a flow path over the thrombus 12 '(FIG. 4) to create a blood flow 14 due to the internal procedure. In this way, the distal segment 1 in the unrestrained state 13 significantly reduces the pressure drop across the thrombus 12 ′ and thus significantly reduces the pressure that would otherwise resist removal of the thrombus 12 ( (Figure 5). Further, the flow path is formed by the distal segment 1 being deployed and in the unrestrained state 13 pulling a significant portion of the periphery of the thrombus 12 'away from the vessel wall. In addition, the deployment of the volume reduction form 6 forms an integrated composite with the mesh embedded within the thrombus. As described above, the distal portion of the volume reduction configuration 6 can generate a large radial force (and can assume a hook-like shape when deployed), thus facilitating removal of the thrombus.

遠位セグメント1が展開されて非拘束状態13にされた後に、元の血栓12の周縁の約10%〜約60%が血管壁から引き離されると推定され、したがって展開後に血栓12'が付着または摩擦によって血管壁に張り付く力が減じられる。さらにまた、展開されて非拘束状態13にされた遠位セグメント1によって元の血栓12の断面積がかなり減少させられる結果、血栓12'の断面積は元の断面積の約30%〜約95%になり、さらに一般には元の断面積の約50%〜約80%になる。この全ての結果、本明細書で後に説明される機能によって示されるように、血栓を引き剥がして可動化する力が減じて血栓を移動させる引張り力19がさらに有効になる結果として、血管再生処置が一層有効になる。さらなる利点には、血栓12'の全長に沿って、またはすくなくとも非拘束状態13にある遠位セグメント1の全長に沿って、減じられた血栓移動力が分散され、装置が血栓を滑り抜けるかまたは、残留血栓、遠位塞栓形成または関わりのない領域における塞栓形成を生じさせ得るであろう、血栓細分化をおこす機会が減じられる。   It is estimated that about 10% to about 60% of the periphery of the original thrombus 12 is pulled away from the vessel wall after the distal segment 1 is deployed and brought into the unrestrained state 13 so that the thrombus 12 ′ is attached or removed after deployment. Friction reduces the force of sticking to the vessel wall. Furthermore, the cross-sectional area of the original thrombus 12 is significantly reduced by the distal segment 1 being deployed and unrestrained 13 so that the cross-sectional area of the thrombus 12 'is about 30% to about 95% of the original cross-sectional area. %, And more generally about 50% to about 80% of the original cross-sectional area. All this results in a revascularization procedure as a result of a more effective pulling force 19 that moves the thrombus by reducing the force to detach and mobilize the thrombus, as shown by the functions described later herein. Becomes more effective. A further advantage is that the reduced thrombus movement force is distributed along the entire length of the thrombus 12 ′, or at least along the entire length of the distal segment 1 in the unconstrained state 13, so that the device can slip through the thrombus or Opportunities for thrombus fragmentation, which could result in residual thrombus, distal embolization or embolization in unrelated areas, are reduced.

標的閉塞は、断面積A(図2a)を有し、付随して血栓にかけて圧力降下Pを生じさせ、血管接触周縁面積Cを有し、fが血栓付着力と摩擦力/接触面積の比に比例する量である、元の血栓12によって表される。この血栓を、血栓にかけて内部処置による血流を確立せず、血栓周縁のかなりの部分を血管壁から引き離さない、既知の方法によって引き剥がすかまたは可動化するに必要な力は、関数:
(A・P)+C・f
で表すことができる。
The target occlusion has a cross-sectional area A (FIG. 2a), concomitantly creates a pressure drop P across the thrombus, has a vascular contact peripheral area C, and f is a ratio of thrombus adhesion and friction force / contact area. It is represented by the original thrombus 12, which is a proportional amount. The force required to pull or mobilize this thrombus in a known manner that does not cause blood flow through the thrombus, establishes a blood flow by internal treatment, and does not separate a significant portion of the thrombus from the vessel wall is a function:
(AP) + Cf
Can be expressed as

本発明の血栓除去方法については、すなわち遠位セグメント1が血栓12'内で展開されて非拘束状態13にある場合(図4)には、縮小された断面積‘a’(a<A)、減じられた血栓にかかる圧力降下‘p’(p<P)、かなり低減された血管接触周縁面積c(c<C)を血栓12'が有し、fは血栓付着力と摩擦力/接触面積の比に比例する量である。本明細書に説明される方法にしたがって血栓12'を引き剥がし、可動化するに必要な力は関数:
(a・p)+c・f
で表すことができ、既知の方法による元の血栓12の引剥し及び可動化に必要な力よりもかなり小さくなるであろう(図5)。
For the thrombus removal method of the present invention, i.e., when the distal segment 1 is deployed in the thrombus 12 'and is in the unrestrained state 13 (FIG. 4), the reduced cross-sectional area' a '(a <A) The thrombus 12 'has a reduced pressure drop on the reduced thrombus'p' (p <P), a significantly reduced vascular contact peripheral area c (c <C), and f is the thrombus adhesion and friction force / contact The amount is proportional to the area ratio. The force required to tear and move the thrombus 12 'according to the method described herein is a function:
(a ・ p) + c ・ f
And will be significantly less than the force required to peel and mobilize the original thrombus 12 by known methods (FIG. 5).

血管からの血栓の一部(図7)または全て(図6)の溶解及び装置の引戻し(図8及び9)の効率を高めて、閉塞された動脈において血流14を回復させる血栓溶解方法及び装置も本発明によって考えられる。先に説明したように、遠位セグメントは、血栓12'内で血栓12'にかけて展開されて、閉塞動脈における血流14を回復させる(図4)。即時の血流14の確立は、血栓で閉塞された大脳動脈の処置のための既知の装置及び方法では血流の回復に数時間かかり得るから、既知の装置及び方法に優る重要な利点である。特定の利点には、虚血組織を灌流するため及び元の閉塞の遠位にあり得る塞栓の破砕に役立たせるための、元の閉塞の遠位での順行流の回復がある。さらなる利点は、血流にさらされる血栓12'の表面積の増大、したがって血栓12'への血液の自然溶解作用の効率の向上及び医師によって投与される、それらの全てが血栓溶解を容易にする、血栓崩壊剤、抗血液凝固剤、抗血小板剤またはその他の医薬品の有効性の向上から得られる。血栓が完全に溶解したか(図6)、または再閉塞はおこりそうもないほど十分に小さい血栓12''(図7)になれば、遠位セグメント1は、遠位セグメント1が動脈内で軸方向に移動しないように押出ワイア7を固定位置に保持しながら、マイクロカテーテル8を前進させて遠位セグメント1の全体に被せることによって、引戻し状態20にされる(図8及び9)。装置は次いでマイクロカテーテル8を通して取り出されるか、あるいは装置の遠位セグメント1を内部に収めたままでマイクロカテーテル8を取り出すことができる。   A method of thrombolysis that restores blood flow 14 in an occluded artery by increasing the efficiency of lysis and device withdrawal (FIGS. 8 and 9) of a portion (FIG. 7) or all (FIG. 6) of a thrombus from a blood vessel; An apparatus is also contemplated by the present invention. As previously described, the distal segment is deployed within the thrombus 12 'over the thrombus 12' to restore blood flow 14 in the occluded artery (FIG. 4). The establishment of immediate blood flow 14 is an important advantage over known devices and methods because known devices and methods for the treatment of cerebral arteries occluded with thrombus can take several hours to restore blood flow. . A particular advantage is the restoration of antegrade flow distal to the original occlusion to help perfuse the ischemic tissue and to disrupt the emboli that may be distal to the original occlusion. Further advantages are an increase in the surface area of the thrombus 12 ′ exposed to the bloodstream, thus increasing the efficiency of the natural dissolution of blood into the thrombus 12 ′ and all of which facilitate the thrombolysis administered by the physician, Obtained from improved effectiveness of thrombolytic agents, anticoagulants, antiplatelet agents or other pharmaceuticals. If the thrombus is completely dissolved (FIG. 6) or becomes a thrombus 12 ″ (FIG. 7) that is small enough that reocclusion is unlikely, the distal segment 1 will become distal within the artery. The microcatheter 8 is advanced and placed over the entire distal segment 1 while holding the pusher wire 7 in a fixed position to prevent axial movement (FIGS. 8 and 9). The device can then be removed through the microcatheter 8, or the microcatheter 8 can be removed while the distal segment 1 of the device remains inside.

さらに、本発明の方法は、血管からの血栓の一部または全ての溶解及び遠位セグメント1の埋込の効率を高めて、閉塞動脈における血流を回復させることができると考えられる。遠位セグメント1の埋込を含む方法には、遠位セグメント1と押出ワイア7の間に解放可能な取付機構をもつ装置の使用が必要である。先に説明したように、遠位セグメント1は、閉塞動脈における血流14を回復させるために、血栓12'内で血栓12'にかけて展開される(図4)。次いで遠位セグメント1は、解放可能な取付機構によって、押出ワイアから取り外され得る。そのような取外しは、血流の回復時に直ちに(図10)、血栓12''が、再閉塞がおこりそうもないほど十分に小さくなったときに(図11)、または血栓が完全に溶解したときに(図12)、行うことができる。   Furthermore, it is believed that the method of the present invention can restore the blood flow in the occluded artery by increasing the efficiency of lysis of some or all of the thrombus from the blood vessel and implantation of the distal segment 1. Methods involving the implantation of the distal segment 1 require the use of a device with a releasable attachment mechanism between the distal segment 1 and the pusher wire 7. As previously described, the distal segment 1 is deployed within the thrombus 12 ′ over the thrombus 12 ′ to restore blood flow 14 in the occluded artery (FIG. 4). The distal segment 1 can then be removed from the pusher wire by a releasable attachment mechanism. Such removal is immediately upon recovery of blood flow (FIG. 10), when the thrombus 12 ″ has become small enough that re-occlusion is unlikely (FIG. 11), or the thrombus has completely dissolved. Sometimes (FIG. 12) it can be done.

本発明の別の実施形態において、血栓の除去または溶解はマイクロカテーテル及び/または誘導カテーテルを吸引することで補助される。   In another embodiment of the invention, removal or lysis of the thrombus is assisted by aspirating the microcatheter and / or guide catheter.

遠位セグメントと押出ワイアの間の解放可能な機構から得られる有用性には、本明細書に開示される方法の全てに対して1つの装置で対応でき、ユーザに処置の選択肢を提供できることがある。さらなる利点の内では、解放可能な機構により、患者からの取出しが可能ではないと判断された場合に、ユーザによる非拘束状態の遠位セグメントの解放が可能になる。   The utility gained from the releasable mechanism between the distal segment and the pusher wire can be addressed with a single device for all of the methods disclosed herein, providing the user with treatment options. is there. Among the additional advantages, the releasable mechanism allows the user to release the unconstrained distal segment if it is determined that removal from the patient is not possible.

本発明のいくつかの実施形態は、血流を回復させ、次いで装置を切り離して装置をその場に残す(図12)方法を含む。これは、装置をもはや引き戻せないと診療医が判断した場合に行うことができる。この実施形態においては、装置は抗血液凝固剤または抗血小板剤でコーティングされるか、そうではなくとも抗血液凝固剤または抗血小板剤に埋め込まれるであろうと考えられる。これは以下でさらに詳しく論じられる。   Some embodiments of the invention include a method of restoring blood flow and then disconnecting the device, leaving the device in place (FIG. 12). This can be done if the clinician determines that the device can no longer be pulled back. In this embodiment, it is envisaged that the device will be coated with an anticoagulant or antiplatelet agent or will otherwise be embedded in the anticoagulant or antiplatelet agent. This is discussed in more detail below.

装置
上述したように、本発明の方法によっていずれか適する自動展開式装置を用いることができる。装置の様々な実施形態を米国特許第7300458号明細書に見ることができる。この明細書はその全体が本明細書に参照として含まれる。
Apparatus As described above, any suitable self-expanding apparatus can be used in accordance with the method of the present invention. Various embodiments of the device can be found in US Pat. This specification is hereby incorporated by reference in its entirety.

図13によれば、遠位セグメント1は、一実施形態において、レーザ溶接法で相互接続された複数本のフィラメントからなる、メッシュ構造またはハニカム構造を有する。遠位セグメント1はさらに機能構造A及び先細り近位構造Bに分けることができ、これらの2つの構造は、とりわけ異なるメッシュサイズによって、弁別することができる。機能構造Aによる機能の実施を可能にするため、メッシュセル23は、血栓12への埋込に適するように、比較的狭く保たれる。一般に、メッシュ幅は0.5〜4mmの範囲にあり、セグ
メント内で変わり得る。
According to FIG. 13, the distal segment 1 has, in one embodiment, a mesh structure or a honeycomb structure consisting of a plurality of filaments interconnected by laser welding. The distal segment 1 can be further divided into a functional structure A and a tapered proximal structure B, which can be distinguished by different mesh sizes, among others. In order to be able to perform the function with the functional structure A, the mesh cell 23 is kept relatively narrow so as to be suitable for implantation into the thrombus 12. Generally, the mesh width is in the range of 0.5-4 mm and can vary within the segment.

本発明の一態様において、遠位セグメント1は、遠位セグメント1が送り込まれる血管の壁との密な接触を確立することができる軸線方向開口物体の形をとるように巻き上げられる、平らなまたは二次元の構造である。   In one aspect of the invention, the distal segment 1 is rolled up to take the form of an axially open object that can establish intimate contact with the wall of the blood vessel into which the distal segment 1 is delivered, flat or It is a two-dimensional structure.

遠位セグメント1の先細り近位構造Bには最小展開効果を有するように最適化された幅広のメッシュセル24構造が備えられている。先細り構造22の領域においては、遠位セグメント1が送り込まれて所定の位置に配置されるときに連結点9にかけられる誘導ワイアの推力及び張力を機能構造Aに効率よく伝達することができるように、フィラメントの太さ及び/または幅が大きくなっている。先細り構造領域において、血管壁に対する支持及び血管壁の掩蔽は通常必要ではないが、他方で、張力及び推力の増大にしたがう必要がある。機能構造Aにおけるフィラメントの太さは一般に0.02mmと0.076mmの間の範囲にあり、近位構造部Bにおけるフィラメントの太さは0.076mmより大きい。   The tapered proximal structure B of the distal segment 1 is provided with a wide mesh cell 24 structure optimized to have a minimal deployment effect. In the region of the tapered structure 22, the thrust and tension of the guide wire applied to the connection point 9 when the distal segment 1 is fed and placed at a predetermined position can be efficiently transmitted to the functional structure A. The thickness and / or width of the filament is increased. In the tapered structure region, support to the vessel wall and occultation of the vessel wall are usually not necessary, but on the other hand, it is necessary to follow an increase in tension and thrust. The filament thickness in functional structure A is generally in the range between 0.02 mm and 0.076 mm, and the filament thickness in proximal structure B is greater than 0.076 mm.

近位構造は連結点9において45°〜120°の角度、特に約90°の角度をなす。メッシュの寸法及び形状は安定性、可撓性、等に関して変化する要件に適合するように広い範囲にわたって変わり得るが、フィラメントの太さ(またはストリング幅)は同じである。近位構造Bも血管壁に接触し、したがって血管内の血流を妨害しないことは当然である。   The proximal structure makes an angle of 45 ° to 120 ° at the connection point 9, in particular about 90 °. The size and shape of the mesh can vary over a wide range to meet changing requirements with respect to stability, flexibility, etc., but the filament thickness (or string width) is the same. Of course, the proximal structure B also contacts the vessel wall and therefore does not interfere with blood flow within the vessel.

遠端において、フィラメント22は、遠位セグメント1の位置決めを容易にする白金マーカーを保持するに適する種類の、一連のテール2で終端する。   At the distal end, the filament 22 terminates in a series of tails 2 of a type suitable for holding a platinum marker that facilitates positioning of the distal segment 1.

遠位セグメント1は、縁端27及び28が少なくとも互いに密接し、末端領域で重なることができるような態様で巻き上げられる。この体積縮小形態において、ワイアメッシュロールと同様の、遠位セグメント1は、そのように形成されたロールが、マイクロカテーテルに送り込まれて、カテーテル内を移動させられ得るような大きさまで、巻き上げられる。マイクロカテーテルから解放されると、巻き上げられた構造が弾けて開き、前もって刷り込まれた重畳構造をとろうとし、そうしている間に処置されるべき血管の内壁に密に寄り添い、よって、その場所に存在する血栓を表面から覆い、次いで血栓内に潜り込む。この場合、「巻き上げ」の程度は血管容積に左右される。血管が細くなるほど遠位セグメント1の縁端27及び28の重なりは大きくなるであろう。一方、血管が太くなるほど重なりは小さくなるか、または「未然重なり」さえ必要になるであろうが、それでも遠位セグメント1が残留張力を示すことを確実にするために当然の注意が払われなければならない。   The distal segment 1 is rolled up in such a way that the edges 27 and 28 are at least in close contact with each other and can overlap in the end region. In this volume reduction configuration, similar to the wire mesh roll, the distal segment 1 is rolled up to such a size that the roll so formed can be fed into the microcatheter and moved through the catheter. When released from the microcatheter, the rolled up structure will pop open, trying to take a pre-printed superimposed structure, while closely snuggling to the inner wall of the blood vessel to be treated, and hence its location The thrombus present in the clot is covered from the surface and then dive into the thrombus. In this case, the degree of “rolling up” depends on the blood vessel volume. The thinner the vessel, the greater the overlap of the edges 27 and 28 of the distal segment 1 will be. On the other hand, the thicker the vessel, the smaller the overlap, or even “pre-overlap” will be required, but of course care must be taken to ensure that the distal segment 1 exhibits residual tension. I must.

デバイスに用いられ得る適切な材料には、形状記憶特性を有する合金がある。最終製品は、刷り込まれた構造が永久的に確立されるように材料に従来印加される温度において、焼戻し処理を受ける。   Suitable materials that can be used in the device include alloys having shape memory properties. The final product is tempered at a temperature conventionally applied to the material so that the imprinted structure is permanently established.

遠位セグメント1は相互に連結されたストリングまたはフィラメントからなるメッシュ様構造を有する。ストリングは、遠位セグメント1が、例えば、冠動脈ステントにしばしば利用されるような、カット構造である場合に用いられ、フィラメントからなるメッシュ様構造は、遠位セグメント1がメリヤス編みまたはモール編みの構造を有するマットの形態または相互に溶接された個々のフィラメントの形態で存在する場合に見られる。   The distal segment 1 has a mesh-like structure consisting of interconnected strings or filaments. A string is used when the distal segment 1 is a cut structure, such as is often used for coronary stents, for example, and a mesh-like structure of filaments is a structure in which the distal segment 1 is knitted or knitted. Present when present in the form of a mat with the following or in the form of individual filaments welded together.

図14は、先細り近位構造Bが中央領域だけでなく周縁領域においても追加フィラメント29によって機能構造部Aと連結されている上述したハニカム構造を有する、本発明にしたがう遠位セグメント1の別の実施形態を示す。追加フィラメント29及び30により、近位構造Bから機能構造Aへの張力及び推力のさらに一様な伝達が達成される。この結果、特にステントを再位置決めしなければならないことからステントをマイクロカテーテル内に引き戻さなければならない場合に、張力をより効率的に伝えることができる。追加フィラメント29,30はステントの再度の巻き上げを容易にする。同様に、ステントが送り出されて所定の位置に配置されるときに生じる推力を、ステントが穏やかにあてがい得るように、伝達することが容易になる。   FIG. 14 shows another embodiment of the distal segment 1 according to the invention having a honeycomb structure as described above in which the tapered proximal structure B is connected to the functional structure A by an additional filament 29 not only in the central region but also in the peripheral region. An embodiment is shown. The additional filaments 29 and 30 achieve a more uniform transmission of tension and thrust from the proximal structure B to the functional structure A. As a result, tension can be transmitted more efficiently, especially when the stent must be pulled back into the microcatheter because it must be repositioned. Additional filaments 29, 30 facilitate the rewinding of the stent. Similarly, it is easy to transmit the thrust generated when the stent is delivered and placed in place so that the stent can be gently applied.

図15は、直線フィラメント29で形成されている縁端27及び28をもつハニカム構造を有する、本発明にしたがう遠位セグメント1の別の実施形態を示す。この実施形態にしたがえば、連結点9において誘導ワイアにより加えられる推力または圧力が機能構造部Aの縁端27及び28に直接に伝えられて、図14を参照して説明した効果をさらに高める。   FIG. 15 shows another embodiment of the distal segment 1 according to the invention having a honeycomb structure with edges 27 and 28 formed of straight filaments 29. According to this embodiment, the thrust or pressure applied by the induction wire at the connection point 9 is directly transmitted to the edges 27 and 28 of the functional structure A, thereby further enhancing the effect described with reference to FIG. .

図15による実施形態は、図13及び14で説明した実施形態と同様に、カットホイルに基づくことができる。すなわち、個々のフィラメント22,29及び30は、カッティング法を用いて処理されたホイルの残余要素である、個々のストリングによって置き換えられる。中空円筒構造を有するステントの作成のためのレーザカッティング法は既知である。ステントに適するパターンの作成のためのホイルの処理は類似の態様で実施される。重畳構造の刷込みはフィラメント構造に対して用いられる方法と同様の方法で行われる。   The embodiment according to FIG. 15 can be based on a cut foil, similar to the embodiment described in FIGS. 13 and 14. That is, the individual filaments 22, 29 and 30 are replaced by individual strings, which are the remaining elements of the foil processed using the cutting method. Laser cutting methods for the production of stents having a hollow cylindrical structure are known. The processing of the foil for creating a pattern suitable for the stent is carried out in a similar manner. The imprinting of the superimposed structure is performed in the same manner as that used for the filament structure.

一実施形態において、それぞれのストリング幅が同じ大きさの展開金属ホイルを用いることができる。一実施形態において、全てのストリングが同じ平面上に確実に配置されるように、続いてホイルを平滑化することが考えられる。ホイル厚は通常、0.02mmと0.2mmの間の範囲にある。さらに厚いホイルにより、例えば冠動脈ステントとしての、あるいは、例えば胆管または尿管を含む身体の別の領域における、別の適用分野でのステントの使用も可能になる。   In one embodiment, unfolded metal foils with the same string width can be used. In one embodiment, it is conceivable to subsequently smooth the foil to ensure that all strings are placed on the same plane. The foil thickness is usually in the range between 0.02 mm and 0.2 mm. The thicker foil also allows the use of the stent in other fields of application, for example as a coronary stent, or in other areas of the body including, for example, the bile duct or ureter.

カッティング法を用いて加工されたホイルは、ばり及びその他の不整を除去して平滑な表面及び丸められたエッジを得るために電気化学的手段によって仕上げられる。当業者であれば、そのような電気化学プロセスは医用技術で既に用いられているから、そのような電気化学プロセスがわかるであろう。この状況において、後から三次元構造が刷り込まれた二次元形状に基づく、本発明にしたがうステントが、作成中に既に三次元構造を有しており、精巧で費用がかかる加工プロセス及び加工装置を必要とする、従来の「中空円筒」ステントより容易に作成及び処理できることに注意すべきである。   Foil processed using the cutting method is finished by electrochemical means to remove flashes and other irregularities to obtain smooth surfaces and rounded edges. One skilled in the art will recognize such electrochemical processes because such electrochemical processes are already used in medical technology. In this situation, a stent according to the present invention, based on a two-dimensional shape that is subsequently imprinted with a three-dimensional structure, already has a three-dimensional structure during its construction, so that an elaborate and costly processing process and processing device are provided. It should be noted that it is easier to make and process than the traditional “hollow cylindrical” stent that is required.

上で指摘したように、本発明にしたがう遠位セグメント1のメッシュ構造は個々のフィラメントのモール編みで形成することができる。そのような編み上げ構造が、個々のフィラメント22がメッシュ様構造31を形成する個々のループ23を有する「シングルジャージー編布」の形態に編み込まれている、図16に示される。このタイプのシングルジャージー品は、一列の編み針から既知の方法で作成される。シングルジャージー品は見た目の異なる2つの面、すなわち編み目の表面及び裏面を有する。シングルジャージー編布材料は、横方向には延びにくく、非常に軽いのが特徴である。   As pointed out above, the mesh structure of the distal segment 1 according to the present invention can be formed by knitting individual filaments. Such a braided structure is shown in FIG. 16 where the individual filaments 22 are knitted in the form of a “single jersey knitted fabric” with individual loops 23 forming a mesh-like structure 31. This type of single jersey product is made in a known manner from a row of knitting needles. A single jersey product has two sides with different appearances: a front and back side of the stitch. The single jersey knitted fabric material is characterized by being very light and difficult to extend in the lateral direction.

個々のストランドのモール編みからなり、ロープの形につくられたフィラメントを用いることもできる。合計太さが0.02mmの12本から14本のストランドでつくられたモール編みを用いることができる。フィラメントのための材料として、白金、白金合金、金及びステンレス鋼を用いることができる。一般に、該当要件を満たす、医用技術で知られている永久的な遠位セグメント1の材料の全てを用いることができる。   It is also possible to use a filament made of a knitting of individual strands and made in the form of a rope. Mole knitting made of 12 to 14 strands having a total thickness of 0.02 mm can be used. Platinum, platinum alloy, gold and stainless steel can be used as the material for the filament. In general, any permanent distal segment 1 material known in the medical art that meets the requirements can be used.

一実施形態において、本明細書で扱われている重畳構造及び用途に関して有益である、ドイツ語の、いわゆる「フルーゼ(Fluse)」織で知られているように巻き上げられている
編み上げ構造の織縁を有することが有利である。この場合、重畳構造は編み上げプロセスを用いて刷り込むことができる。しかし、この場合も形状記憶合金の使用が可能であり、有用である。
In one embodiment, a knitted edge of a braided structure wound up as known in German, so-called "Fluse" weave, which is beneficial with respect to the superimposed structures and applications addressed herein. It is advantageous to have In this case, the superimposed structure can be imprinted using a knitting process. However, in this case, a shape memory alloy can be used and is useful.

そのような編み上げ構造の作成に対し、既知の編み上げプロセス及び手法を用いることができる。しかし、本発明にしたがう遠位セグメントは寸法が極めて小さい、−例えば2×1cm−から、例えば横編みまたは縦編みの編布がそこから始まるかまたはそのような編布から広がるそれぞれの金属フィラメントからなる縁の形態で、非金属フィラメントである紡織繊維の従来の縦編みまたは横編みの編布の枠組みにおいて遠位セグメントを作成することが有益であることがわかった。横編みまたは縦編みの編布の金属部分の縁への配置によって上述した巻き上げ効果が達成される。編布の非金属部分は最終的に、灰化、化学分解または適する溶剤を用いる溶解によって除去される。   Known knitting processes and techniques can be used to create such a knitted structure. However, the distal segment according to the invention is of very small dimensions, for example from 2 × 1 cm—from each metal filament from which, for example, a weft or warp knitted fabric starts or spreads out from such a knitted fabric It has been found that it is beneficial to create a distal segment in the framework of a conventional warp or weft knitted fabric of textile fibers that are non-metallic filaments. The winding effect described above is achieved by arranging the flat or warp knitted fabric on the edge of the metal part. The non-metallic part of the knitted fabric is finally removed by ashing, chemical decomposition or dissolution with a suitable solvent.

図1は、誘導ワイア7と誘導ワイア7に取り付けられた、溶接によって相互に連結されたフィラメントからなる、遠位セグメント1の組合せを示す。縁端2及び、遠位セグメント1のフィラメントが先細り構造に収斂し、同時に誘導ワイア7との結合場所に相応する、連結点9が示される。誘導ワイア7は従来品のマイクロカテーテル8に送り込まれる。   FIG. 1 shows a combination of a distal segment 1 consisting of a guide wire 7 and filaments attached to the guide wire 7 interconnected by welding. The connection point 9 is shown, in which the filaments of the edge 2 and the distal segment 1 converge in a tapered structure and at the same time correspond to the connection location with the guide wire 7. The guide wire 7 is fed into a conventional microcatheter 8.

カテーテル8内で誘導ワイア7を移動させると、遠位セグメント1はカテーテルから押し出されるかまたはカテーテルに引き込まれるであろう。ステントがマイクロカテーテル8から押し出されるとメッシュ様構造は刷り込まれている重畳構造をとろうとし、引き込まれるときにメッシュ構造は利用できる内部空間に適合するように折り畳まれてマイクロカテーテル8内に戻る。   Moving the guide wire 7 within the catheter 8 will cause the distal segment 1 to be pushed out of or pulled into the catheter. When the stent is pushed out of the microcatheter 8, the mesh-like structure attempts to take a superimposed structure that is imprinted, and when retracted, the mesh structure is folded to fit into the available internal space and returned into the microcatheter 8.

メッシュ構造の剛性の結果、遠位セグメント1は、血管系内で最適に位置決めされるまで、事実上拘束されずに誘導ワイア7によって前後に移動させることができる。   As a result of the stiffness of the mesh structure, the distal segment 1 can be moved back and forth by the guide wire 7 virtually unconstrained until it is optimally positioned within the vasculature.

先述したように、従来のマイクロカテーテルを用いることができる。しかし、本発明にしたがう遠位セグメント1及び本発明にしたがう遠位セグメント1と誘導ワイアの組合せの一利点は、従来の誘導ワイア/マーカーシステムによってマイクロカテーテルを所定の位置に配した後に、本発明にしたがう誘導ワイア7と遠位セグメント1の組合せをマイクロカテーテルに送り込み、埋込部位に向けてマイクロカテーテルを通して移動させ、次いで、外に出してその部位にあてがい得ることである。あるいは、より小径の第2のマイクロカテーテルに誘導ワイア7及び遠位セグメント1を収め、初めに配置されたマイクロカテーテル内でこの第2のマイクロカテーテルによって誘導ワイア7及び遠位セグメント1を埋込部位に移動させることが可能であろう。いずれの場合にも、遠位セグメント1を両方向に容易に誘導することができる。   As described above, a conventional microcatheter can be used. However, one advantage of the distal segment 1 according to the present invention and the combination of the distal segment 1 and the guide wire according to the present invention is that after the microcatheter is placed in place by a conventional guide wire / marker system, the present invention Thus, the combination of guide wire 7 and distal segment 1 can be fed into the microcatheter and moved through the microcatheter toward the implantation site and then out and applied to that site. Alternatively, the guide wire 7 and the distal segment 1 are housed in a second microcatheter having a smaller diameter, and the guide wire 7 and the distal segment 1 are implanted by the second microcatheter within the initially placed microcatheter. It would be possible to move to In either case, the distal segment 1 can be easily guided in both directions.

図17a及び17bは、重畳形状すなわち体積拡大形状及び体積縮小形状にある本発明の遠位セグメント1の略図を示す。図17aに示されるように、展開形状において、遠位セグメント1は縁端27及び28が若干重なるリング形構造をとる。図17aにおいて、遠位セグメント1は、近端から見た、連結点9が縁端27及び28にほぼ対向して配置されている上面図として示される。本発明にしたがう組合せにおいて、誘導ワイア7は連結点9に取り付けられる。   Figures 17a and 17b show a schematic representation of the distal segment 1 of the present invention in a superimposed shape, ie, a volume expansion shape and a volume reduction shape. As shown in FIG. 17a, in the deployed configuration, the distal segment 1 has a ring-shaped structure with edges 27 and 28 slightly overlapping. In FIG. 17a, the distal segment 1 is shown as a top view with the connecting point 9 positioned substantially opposite the edges 27 and 28, as viewed from the proximal end. In the combination according to the invention, the guide wire 7 is attached to the connecting point 9.

図17bは、例えば巻き上げられた状態でマイクロカテーテル内に配置されているような、体積縮小形態6にある同じ遠位セグメント1を示す。図示されている場合において、巻き上げられた遠位セグメント1の総巻き数は2であり、連結点9が近位側に配置され、2つの横縁27及び28がロールまたはコイルの出発点及び最終点である。この構造は体積縮小形態でマイクロカテーテル8によって保持され、遠位セグメント1がマイクロカテーテル8から押し出されるとゼンマイと同様に弾けて、図17aに示されるように、展開形状になる。   FIG. 17b shows the same distal segment 1 in a volumetric configuration 6 as it is placed in a microcatheter, for example in a rolled up state. In the case shown, the total number of turns of the wound up distal segment 1 is 2, the connection point 9 is located proximally, and the two lateral edges 27 and 28 are the starting and final points of the roll or coil. Is a point. This structure is held by the microcatheter 8 in a reduced volume configuration, and when the distal segment 1 is pushed out of the microcatheter 8, it springs in the same manner as the mainspring and becomes a deployed shape, as shown in FIG. 17a.

図18aは本発明にしたがう遠位セグメント1に適するマーカー素子15を示し、マーカー素子15は遠位セグメント1の遠端に配置することができる。マーカー素子15はラグ33を有し、ラグ33はラグ33の内部に平らに、すなわち突き出す要素は全くなしに遠位セグメント1の平面と同一面に、配置された小さなマーカープレート35を備える。プレート35はX線反射性材料、例えば白金または白金−イリジウムでつくられる。マーカープレート35は既知のレーザ溶接法によって周囲の遠位セグメント1に結合させることができる。図18bに示されるように、マーカー素子15は遠位セグメント1の遠端に配置される。   FIG. 18 a shows a marker element 15 suitable for the distal segment 1 according to the invention, which can be arranged at the distal end of the distal segment 1. The marker element 15 has a lug 33 which comprises a small marker plate 35 which is arranged flat inside the lug 33, i.e. flush with the plane of the distal segment 1 without any protruding elements. The plate 35 is made of an X-ray reflective material such as platinum or platinum-iridium. The marker plate 35 can be coupled to the surrounding distal segment 1 by known laser welding methods. As shown in FIG. 18 b, the marker element 15 is arranged at the distal end of the distal segment 1.

上述したように、一実施形態において装置は、除去可能な、一体化された装置−血栓複合体が得られるように構成される。この構成は様々な態様でなされ得る。例えば、図18cに見られるように、マーカー素子15'はコイルにして設けることができ、よってメッシュ構造の遠端の支持強度を高め、血栓取出しを補助することができる。また図18dに見られるように、マーカー素子15''はコイルマーカー15'と同様の態様で機能するアイレット形として設けることができる。図18eは、除去中の血栓保持力をさらに与えるために付加することができるフックまたはペグの形状で示される、マーカー素子15'''
を示す。マーカー素子15'''は必要に応じてX線不透過性であるか、あるいはメッシュ構造と同じ形状記憶合金で作成することができる。
As described above, in one embodiment, the device is configured to provide a removable, integrated device-thrombotic complex. This configuration can be done in various ways. For example, as seen in FIG. 18c, the marker element 15 ′ can be provided as a coil, thus increasing the support strength of the distal end of the mesh structure and assisting in thrombus removal. Also, as seen in FIG. 18d, the marker element 15 '' can be provided as an eyelet shape that functions in a manner similar to the coil marker 15 '. FIG. 18e shows a marker element 15 ′ ″, shown in the form of a hook or peg that can be applied to further provide thrombus retention during removal.
Indicates. The marker element 15 '''can be radiopaque, if desired, or made of the same shape memory alloy as the mesh structure.

除去可能な、一体化された血栓−装置複合体を得るために考えられる別の構造形状には、(1)メッシュ構造の近端に比較して直径が大きい遠位セグメント1の最も遠位の位置におけるメッシュ構造(または遠位セグメント1の遠端の巻きテーパ)、(2)遠位セグメント1の最も遠位に配置された第3の複数のメッシュセル、この第3の複数のメッシュセルのメッシュ寸法は第1の複数のメッシュセルに比較して小さい、(3)メッシュ構造への合成高分子材または高分子ファイバの付加、及び(4)より良好な血栓保持のために強められた径方向力を与えるに十分な時間をかけた遠位セグメント1の遠端の加熱、がある。   Other structural shapes conceivable for obtaining a removable, integrated thrombus-device complex include (1) the most distal of distal segment 1 having a large diameter compared to the proximal end of the mesh structure. Mesh structure in position (or distal taper taper of distal segment 1), (2) a third plurality of mesh cells disposed distally of distal segment 1, of the third plurality of mesh cells The mesh size is small compared to the first plurality of mesh cells, (3) increased diameter for addition of synthetic polymer or polymer fiber to the mesh structure, and (4) better thrombus retention There is heating of the distal end of the distal segment 1 with sufficient time to provide directional force.

上述したように、ファイバをメッシュ構造に付加することができる。ファイバは、メッシュ構造を包み込むかまたはメッシュ構造に巻き付けることができる。ファイバは無固定端を有することができ、あるいは遠位セグメント1全体にわたって完全に編み込むことができる。   As described above, fibers can be added to the mesh structure. The fiber can wrap around or wrap around the mesh structure. The fiber can have an unfixed end or it can be woven completely over the distal segment 1.

適するファイバは米国特許出願公開第2006/0036281号明細書に教示され、
この明細書はその全体が本明細書に参照として含まれる。いくつかの実施形態において、ファイバは高分子材料からなることができる。高分子材料には身体へのインプラントとしての使用が認可されているかまたはそのように認可され得るであろう材料を含めることができる。そのような材料は、ポリエチレン、ポリアクリル、ポリプロピレン、ポリ塩化ビニル、ナイロン、例えばナイロン6.6のようなポリアミド、ポリウレタン、ポリビニルピロリドン、ポリビニルアルコール、ポリ酢酸ビニル、酢酸セルロース、ポリスチレン、ポリテトラフルオロエチレン、ポリエチレンテレフタレート(ダクロン)のようなポリエステル、絹、綿、等のような、非生分解性高分子材とすることができる。いくつかの特定の実施形態において、高分子材コンポーネントのための非生分解性材料には、ポリエステル、ポリエーテル、ポリアミド及びポリフルオロカーボンを含めることができる。
Suitable fibers are taught in U.S. Patent Application Publication No. 2006/0036281,
This specification is hereby incorporated by reference in its entirety. In some embodiments, the fiber can be made of a polymeric material. The polymeric material can include materials that are or could be approved for use as implants in the body. Such materials include polyethylene, polyacrylic, polypropylene, polyvinyl chloride, nylon, polyamide such as nylon 6.6, polyurethane, polyvinyl pyrrolidone, polyvinyl alcohol, polyvinyl acetate, cellulose acetate, polystyrene, polytetrafluoroethylene. Non-biodegradable polymer materials such as polyester such as polyethylene terephthalate (Dacron), silk, cotton, and the like can be used. In some specific embodiments, non-biodegradable materials for the polymeric component can include polyesters, polyethers, polyamides, and polyfluorocarbons.

高分子材は生分解性とすることもできる。代表的な生分解性高分子材には、ポリグリコール酸/ポリ乳酸(PGLA)、ポリカプロラクトン(PCL)、ポリヒドロキシブチレート酪酸吉草酸(PHBV)、ポリオルトエステル(POE)、ポリエチレンオキシド/ポリブチレンテレフタレート(PEO/PBTP)、ポリ乳酸(PLA)、ポリグリコール酸(PGA)、ポリ(p-ジオキサノン)、ポリ(バレロラクトン)、ポリ(タルトロン酸)、ポリ(βマロン酸)、ポリ(プロピレンフマラート)、ポリ(無水物)及びチロシンベースポリカーボネートがある。考えられる別の高分子材にはポリグリコリド及びポリ-L-ラクチドがある。   The polymeric material can also be biodegradable. Typical biodegradable polymer materials include polyglycolic acid / polylactic acid (PGLA), polycaprolactone (PCL), polyhydroxybutyrate butyrate valeric acid (PHBV), polyorthoester (POE), polyethylene oxide / poly Butylene terephthalate (PEO / PBTP), polylactic acid (PLA), polyglycolic acid (PGA), poly (p-dioxanone), poly (valerolactone), poly (tartronic acid), poly (β-malonic acid), poly (propylene) Fumarates), poly (anhydrides) and tyrosine-based polycarbonates. Other possible polymeric materials are polyglycolide and poly-L-lactide.

上述した材料のいずれかの立体異性体を含むが、これらには限定されない、他の等価な材料も用いることができる。   Other equivalent materials can be used including, but not limited to, any of the stereoisomers of the materials described above.

図19a及び19bは、本発明にしたがう遠位セグメント1が取外し可能な態様で誘導ワイア7に連結される、2種の分離機構のそれぞれを示す。それぞれの場合に、分離機構は、電解質に接していると電気エネルギーの影響の下で溶解する亜鈴形素子43を有する。図19aによれば、亜鈴形分離素子43の近端(誘導ワイア側)において、誘導ワイア7の補強コイル46と相互作用するコイル構造45が配置される。遠端には、レーザ溶接法を用いて白金コイル48に結合された球形素子47が配置され、白金コイル48はさらに遠位セグメント1の近端にある連結点9に連結される。白金コイル48は遠位セグメント1のX線反射性近端マーカーとしてもはたらく。   Figures 19a and 19b show each of the two separation mechanisms in which the distal segment 1 according to the present invention is connected to the guide wire 7 in a removable manner. In each case, the separation mechanism has dumbbell elements 43 that dissolve under the influence of electrical energy when in contact with the electrolyte. According to FIG. 19 a, a coil structure 45 that interacts with the reinforcing coil 46 of the induction wire 7 is arranged at the proximal end (induction wire side) of the dumbbell-shaped separation element 43. At the far end, a spherical element 47 coupled to the platinum coil 48 using a laser welding method is disposed, and the platinum coil 48 is further connected to a connection point 9 at the proximal end of the distal segment 1. The platinum coil 48 also serves as an X-ray reflective near end marker for the distal segment 1.

球形素子47と連結点9の間の結合を補強するため、補強ワイア49を備えることができる。あるいは、白金コイル48にかかる張力及び推力に白金コイル48が耐えるような態様に白金コイル48を構成することもできる。   In order to reinforce the connection between the spherical element 47 and the connection point 9, a reinforcing wire 49 can be provided. Alternatively, the platinum coil 48 can be configured in such a manner that the platinum coil 48 can withstand the tension and thrust applied to the platinum coil 48.

分離素子43は、電解質内では電気エネルギーの影響の下で腐蝕されやすい鋼材を有することができる。腐蝕を加速し、分離に要する時間を短縮するため、亜鈴形素子43の、例えば研削法または熱処理を加えることによる、構造的または化学的な弱化が有益であり得る。   The separation element 43 can include a steel material that is easily corroded under the influence of electrical energy in the electrolyte. In order to accelerate corrosion and reduce the time required for separation, structural or chemical weakening of the dumbbell element 43, for example by applying a grinding method or heat treatment, can be beneficial.

一般に、電解質に接し得る亜鈴形素子43の部分の長さは0.1〜0.5mmであり、特に0.3mmである。   In general, the length of the portion of the dumbbell-shaped element 43 that can come into contact with the electrolyte is 0.1 to 0.5 mm, particularly 0.3 mm.

コイル構造45は、亜鈴形素子43及び誘導ワイア7の補強コイル7のいずれにも、溶接によって確実に取り付けられる。誘導ワイア7自体はマイクロカテーテル8内に滑動可能な態様で収められる。   The coil structure 45 is securely attached to both the dumbbell-shaped element 43 and the reinforcing coil 7 of the induction wire 7 by welding. The guide wire 7 itself is housed in the microcatheter 8 in a slidable manner.

図19bは図19aに関して説明した実施形態とは亜鈴形素子43がそれぞれの末端に球形素子47を有する点において異なる第2の実施形態を示す。球形素子47は、遠端においてコイル48によって遠位セグメント1の連結点9に結合され、近端においてコイル46によって誘導ワイア7に結合される。   FIG. 19b shows a second embodiment which differs from the embodiment described with respect to FIG. 19a in that the dumbbell-shaped element 43 has a spherical element 47 at each end. The spherical element 47 is coupled to the connection point 9 of the distal segment 1 by a coil 48 at the far end and to the guide wire 7 by a coil 46 at the near end.

例えば機械的原理またはプラスチック連結素子の溶解に基づく、別の分離原理も適用できることは当然である。   Of course, other separation principles can also be applied, for example based on mechanical principles or melting of plastic connecting elements.

コーティングされた装置
本発明では抗血液凝固性及び/または抗血小板性の薬剤で装置をコーティングすることも考えられる。薬剤は単独でまたは別の薬剤と組み合わせて用いることができると考えられる。
Coated devices The present invention also contemplates coating devices with anticoagulant and / or antiplatelet agents. It is contemplated that the drug can be used alone or in combination with another drug.

抗血液凝固剤または抗凝固剤は血塊形成を防止する作用物質である。抗血液凝固剤の例には、トロンビン選択性阻害薬、第IXa因子、第Xa因子、第XI因子、第XIa因子、第XIIa因子または第VIIa因子、ヘパリン及びヘパリン誘導体、ビタミンK拮抗薬、及び抗組織因子抗原があり、さらにP-セレクチン及びPSGL-1の阻害薬もあるが、これらには限定されない。トロンビン選択性阻害薬の例には、ヒルジン、ビバリルジン(Angiomax(登録商標))、アルガトロバン、キシメラガトラン(Exanta(登録商標))、ダビガトラン、及びレピルジン(Refludan(登録商標))がある。ヘパリン及びヘパリン誘導体の例には、未分画ヘパリン(UFH)、エノキサパリン(Lovenox(登録商標))、ダルテパリン(Fragmin(登録商標))及びダナパロイド(Orgaran(登録商標))のような低分子量ヘパリン(LMWH)、及び、フォンダパリナックス(Arixtra(登録商標))、イドラパリナックス及びビオチン化イドラパリナックスのような合成五糖類がある。ビタミンK拮抗薬の例には、ワルファリン(Coumadin(登録商標))、フェノクマロール、アセノクマロール(Sintrom(登録商標))、クロリンジオン、ジクマロール、ジフェナジオン、エチルビスクムアセテート、フェンプロクモン、フェニンジオン、及びチオクロマロールがある。   Anticoagulants or anticoagulants are agents that prevent clot formation. Examples of anticoagulants include thrombin selective inhibitors, factor IXa, factor Xa, factor XI, factor XIa, factor XIIa or factor VIIa, heparin and heparin derivatives, vitamin K antagonists, and There are anti-tissue factor antigens, but there are also, but not limited to, inhibitors of P-selectin and PSGL-1. Examples of thrombin selective inhibitors are hirudin, bivalirudin (Angiomax®), argatroban, ximelagatran (Exanta®), dabigatran, and repirudin (Refludan®). Examples of heparin and heparin derivatives include low molecular weight heparins such as unfractionated heparin (UFH), enoxaparin (Lovenox®), dalteparin (Fragmin®) and danaparoid (Orgaran®). LMWH) and synthetic pentasaccharides such as fondaparinux (Arixtra®), idraparinux and biotinylated idraparinux. Examples of vitamin K antagonists include warfarin (Coumadin®), phenocumarol, acenocoumarol (Sintrom®), chlorindione, dicoumarol, diphenadione, ethylbiscumacetate, fenprocumone, pheninedione, And thiochromalol.

抗血小板剤または血小板阻害薬は血小板の凝集を防止することにより血塊の形成を妨げる作用物質である。アブシキシマブ(ReoPro(登録商標))、エピチフィバチド(Integrilin(登録商標))及びチロフィバン(Aggrasta(登録商標))のようなGPIIb/IIIa拮抗薬、クロピドグレル(Plavix(登録商標))、チクロピジン(Ticlid(登録商標))、カングレロール、チカグレロル及びプラスグレルのようなP2Y12受容体拮抗薬、シロスタゾール(Pletal(登録商標))、ジピリダモール(Persantine(登録商標))及びAggrenox(登録商標)(アスピリン/徐放ジピリダモール)のようなホスホジエステラーゼIII(PDEIII)阻害薬、フレグレラート、オザグレル、リドグレル及びイスボグレルのようなトロンボキサン合成酵素阻害薬、イフェトロバン、ラマトロバン、テルボグレル、(仏国クールブボア(Courbevoie),deRecherchesInternationalesServierのServier S 18886としても知られる)3-{6-[(4-クロロフェニルスルホニル)アミノ]-2-メチル-5,6,7,8-1-テトラヒドロナフチル}プロピオン酸のようなトロンボキサンA2受容体拮抗薬(TP拮抗薬)、(米国特許出願公開第2004/0192753A1号明細書及び第2004/0176418A1号明細書に説明され、非緊急経皮冠動脈介入を受ける被験者でSCH530348の安全性を評価するための、多施設/無作為/二重盲検/偽薬対照治験のような、臨床試験において試験されている(ClinicalTrials.govID番号NCT00132912)、米国ニュージャージー州,ScheringPloughCorp.の、化学名がエチル(1R,3aR,4aR,6R,8aR,9S,9aS)-9-((E)-2-(5-(3-フルオロフェニル)-2-ピリジニル)ビニル)-1-メチル-3-オキソドデカヒドロナフト[2,3-C]-6-フラニルカルバメートの)SCH530348のようなトロンビン受容体拮抗薬、(米国ニュージャージー州,WyethのPSI-697としても知られる)2-(4-クロロベンジル)-3-ヒドロキシ-7,8,9,10-テトラヒドロベンゾ[H]キノリン-4-カルボン酸のようなP-セレクチン阻害薬、及び、アセチルサリチル酸(アスピリン(登録商標))、レスベラトール、イブプロフェン(Advil(登録商標),Motrin(登録商標))、ナプロキセン(Aleve(登録商標),Naprosyn(登録商標))、スリンダク(Clinoril(登録商標))、インドメタシン(Indocin(登録商標))、メフェナム酸、ドロキシカム、ジクロフェナク(Cataflam(登録商標),Voltaren(登録商標))、スルフィンピラゾン(Anturane(登録商標))及びピロキシカム(Feldene(登録商標))のような非ステロイド性抗炎症薬(NSAIDS)を含む、それぞれの作用に基づく、抗血小板剤のいくつかの種別がある。NSAIDSの中では、アセチルサリチル酸(ASA)、レスベラトール及びピロキシカムが好ましい。アスピリン及びイブプロフェンのようないくつかのNSAIDSは、シクロオキシゲナーゼ-1(cox-1)及びシクロオキシゲナーゼ-2(cox-2)のいずれをも阻害する。cox-2を弱くしか阻害しない可逆的cox-1阻害薬である、レスベラトールのようないくつかのNSAIDSは、cox-1を選択的に阻害する。 Antiplatelet agents or platelet inhibitors are agents that prevent clot formation by preventing platelet aggregation. GPIIb / IIIa antagonists such as abciximab (ReoPro®), epitifibatide (Integrilin®) and tirofiban (Aggrasta®), clopidogrel (Plavix®), ticlopidine (Ticlid®) )), P2Y 12 receptor antagonists such as cangrelor, ticagrelor and prasugrel, cilostazol (Pletal®), dipyridamole (Persantine®) and Aggrenox® (aspirin / sustained release dipyridamole) Phosphodiesterase III (PDEIII) inhibitors, thromboxane synthase inhibitors such as fraggrelate, ozagrel, ligogrel and isvogrel, ifetroban, ramatroban, tervogrel, (also known as Couriervoir, France, Serber S 18886 of deRecherches InternationalesServier) 3- {6-[(4-chlorophenylsulfonyl) Thromboxane A2 receptor antagonists (TP antagonists) such as amino] -2-methyl-5,6,7,8-1-tetrahydronaphthyl} propionic acid, (US 2004/0192753 A1) And 2004 / 0176418A1, such as a multicenter / random / double-blind / placebo-controlled trial to evaluate the safety of SCH 530348 in subjects undergoing non-emergency percutaneous coronary intervention, Tested in clinical trials (ClinicalTrials.gov ID number NCT00132912), ScheringPlough Corp., New Jersey, USA, with the chemical name ethyl (1R, 3aR, 4aR, 6R, 8aR, 9S, 9aS) -9-((E)- 2- (5- (3-fluorophenyl) -2-pyridinyl) vinyl) -1-methyl-3-oxododecahydronaphtho [2,3-C] -6-furanylcarbamate) Thrombin receptor antagonist, 2- (4-chlorobenzyl) -3-hydroxy-7,8,9,10-tetrahydrobenzo [H] quinoline (also known as PSI-697, Wyeth, NJ) P-selectin inhibitors such as 4-carboxylic acid, and acetylsalicylic acid (Aspirin®), resveratrol, ibuprofen (Advil®, Motrin®), naproxen (Aleve®, Naprosyn®), sulindac (Clinoril®), indomethacin (Indocin®), mefenamic acid, droxicam, diclofenac (Cataflam®, Voltaren®), sulfinpyrazone (Anturane There are several types of antiplatelet agents based on their actions, including non-steroidal anti-inflammatory drugs (NSAIDS) such as (R) and piroxicam (Feldene (R)). Among NSAIDS, acetylsalicylic acid (ASA), resveratrol and piroxicam are preferred. Some NSAIDS, such as aspirin and ibuprofen, inhibit both cyclooxygenase-1 (cox-1) and cyclooxygenase-2 (cox-2). Some NSAIDS, such as resveratrol, are reversible cox-1 inhibitors that only weakly inhibit cox-2, selectively inhibit cox-1.

一実施形態において、薬剤の制御された送出は薬剤の細胞溶解効果を制御でき、虚血性脳梗塞及び多くのその他の血管病を処置することができる。放出速度は、薬剤の約50%を約1分から約120分内に血栓に送ることができるように制御することができる。この制御された送出は以下の態様の内の1つないしさらに多くで達成することができる。第1に、薬剤と高分子材の混合物をステントに塗布することができ、高分子材の量を増やすかまたは混合物塗布層を厚くすることができる。第2に、初めにステントを高分子材でコーティングし、次に薬剤と高分子材の層でコーティングし、次に高分子材の表面コーティングを施すことができる。薬剤の放出速度はそれぞれの層の厚さを調節することで変えることができる。第3に、薬剤を保持するための貯槽を備えるようにステントを作成することができる。この実施形態において、薬剤はステントの表面につくられた小貯槽に満たされる。貯槽は、レーザカッティング、機械/電気化学加工、機械加工または化学処理によって作成することができる。   In one embodiment, controlled delivery of the drug can control the cytolytic effect of the drug and can treat ischemic cerebral infarction and many other vascular diseases. The release rate can be controlled such that about 50% of the drug can be delivered to the thrombus within about 1 to about 120 minutes. This controlled delivery can be accomplished in one or more of the following aspects. First, a mixture of drug and polymer material can be applied to the stent, and the amount of polymer material can be increased or the mixture application layer can be thickened. Second, the stent can be first coated with a polymeric material, then coated with a drug and polymeric layer, and then a polymeric surface coating. The drug release rate can be varied by adjusting the thickness of each layer. Third, the stent can be made to include a reservoir for holding the drug. In this embodiment, the drug is filled into a small reservoir created on the surface of the stent. The reservoir can be created by laser cutting, mechanical / electrochemical processing, machining or chemical processing.

説明したばかりの実施形態において、高分子材は生体適合性及び生分解性である。そのような高分子材は技術上周知である。   In the embodiment just described, the polymeric material is biocompatible and biodegradable. Such polymeric materials are well known in the art.

さらに、ステントは高分子材と医薬品の組合せのような薬剤溶出コーティングでコーティングすることができる。そのようなコーティングは、浸漬、スプレー、塗装及び刷毛塗りのような、技術上十分に確立された方法を用いて施すことができる。米国特許第6214115号明細書、米国特許第6153252号明細書、米国特許出願公開第2002/0082679号明細書、米国特許第6306166号明細書、米国特許第6517889号明細書、米国特許第6358556号明細書、米国特許第7318945号明細書、米国特許第7438925号明細書を参照されたい。   In addition, the stent can be coated with a drug eluting coating, such as a combination of a polymeric material and a pharmaceutical. Such coatings can be applied using methods well established in the art, such as dipping, spraying, painting and brushing. US Pat. No. 6,214,115, US Pat. No. 6,153,252, US 2002/0082679, US Pat. No. 6,306,166, US Pat. No. 6,178,889, US Pat. No. 6,358,556 U.S. Pat. No. 7,318,945 and U.S. Pat. No. 7,438,925.

例えば、チュジック(Chudzik)等(米国特許第6344035号明細書)は、医薬品また
は薬剤がポリ(ブチルメタクリレート)及びポリ(エチレン酢酸ビニル共重合体)のような高分子材の混合物と組み合わせて施される方法を教示している。グルワイヤ(Gueuwaiya)等
は、医薬品が乾燥し超微粉砕された形態で粘着性の下塗層上に施される、ステントをコーティングするための方法を開示している(米国特許第6251136号明細書)。ディング(Ding)等は、高分子材と医薬品の実質的に均一な複合層を形成するためにスプレーまたは浸漬によって溶液がデバイス上に順次にまたは同時に与えられる、溶剤を用いる薬剤放出高分子材コーティングを施す方法を教示している(米国特許第5980972号明細書)。
For example, Chudzik et al. (US Pat. No. 6,344,035) is applied in which a pharmaceutical or drug is combined with a mixture of polymeric materials such as poly (butyl methacrylate) and poly (ethylene vinyl acetate copolymer). Teaches how to Gueuwaiya et al. (US Pat. No. 6,251,136) discloses a method for coating a stent in which a pharmaceutical is applied on an adhesive subbing layer in a dried and micronized form. ). Ding et al. Uses solvent-based drug-release polymeric coatings where solutions are applied sequentially or simultaneously by spraying or dipping to form a substantially uniform composite layer of polymeric material and drug. Is taught (US Pat. No. 5,980,972).

本発明の様々な例示的実施形態を開示したが、本発明の利点のいくつかを本発明の精神及び範囲を逸脱することなく達成するであろう変更及び改変がなされ得ることが当業者には明らかであろう。同じ機能を実施する別のコンポーネントで適切に置き換え得ることが当業者には明らかであろう。   While various exemplary embodiments of the invention have been disclosed, those skilled in the art will recognize that changes and modifications may be made that would achieve some of the advantages of the invention without departing from the spirit and scope of the invention. It will be clear. It will be apparent to those skilled in the art that other components that perform the same function may be appropriately replaced.

1 遠位セグメント
2 遠位セグメント遠端
3 遠位セグメント近端
4 本体部分
5 重畳構造
6 体積縮小形態
7 押出ワイア
8 マイクロカテーテル
9 連結点
10 取付機構
11 大脳動脈
12,12' 血栓
13 非拘束状態
14 血流
15 X線不透過性遠位セグメント遠端マーカー
16 マイクロカテーテル遠位先端
17 X線不透過性マイクロカテーテル遠位マーカー
18 X線不透過性遠位セグメント近端マーカー
19 引張力
DESCRIPTION OF SYMBOLS 1 Distal segment 2 Distal segment distal end 3 Distal segment proximal end 4 Main body part 5 Superimposition structure 6 Volume reduction form 7 Push-out wire 8 Microcatheter 9 Connection point 10 Attachment mechanism 11 Cerebral artery 12, 12 'Thrombus 13 Unconstrained state 14 Blood flow 15 Radiopaque distal segment distal end marker 16 Microcatheter distal tip 17 Radiopaque microcatheter distal marker 18 Radiopaque distal segment near end marker 19 Tensile force

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装置またはシステムまたは方法。Device or system or method.
JP2018068017A 2008-02-22 2018-03-30 Methods and apparatus for blood flow restoration Pending JP2018099630A (en)

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